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Probe into flu jab ‘quality defect’

The investigation was initiated in October and involves reports of “bent needles and bent needle caps”.

The issue was first raised at the October Board meeting of the HPRA, minutes of which were seen by the Medical Independent (MI) under a Freedom of Information request.

A HPRA spokesperson said that it “and (the) HSE worked to ensure that continuity of vaccine supply was not affected by this issue”.

The HPRA added that it “assessed the defect as not likely to cause serious harm” and “the defect rate was also low”.

“Approximately 30 units were found to be affected by this issue,” said the spokesperson.

“850,000 were distributed to the Irish market for the 2014/2015 vaccination season. This represents a rate of 0.004 per cent of units distributed to the Irish market.”

The HPRA added the defect was “readily identifiable in the units that were found to be affected, and a communication was issued to healthcare professionals to advise them to inspect the syringes prior to use for the presence of bent needle caps or bent needles, and not to use any syringe with a bent needle or bent needle cap”.

The investigation, begun in October, continues.

“An investigation into reports of bent needles and bent needle caps affecting units of the product Influvac was initiated by the HPRA in October 2014,” the HPRA spokesperson told MI.

“Abbott Healthcare Products Ltd is the marketing authorisation holder for the Influvac product and HPRA has had detailed interactions with Abbott in relation to this issue.

“Although several risk-reducing actions were taken to protect patients at that time, the investigation into the cause of the defective needles is still ongoing. Abbott was the sole supplier to the HSE for the 2014/2015 flu vaccine service.

“The investigation by Abbott into the cause of the bent needles and to identify the appropriate preventative actions is ongoing. After notification of the issue to the HPRA, the inspection of stock commenced at the HPRA’s request for evidence of the defect and to detect (and remove) any other defective units.

“We are continuing to oversee Abbott’s investigation into this matter.”

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