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HPRA concludes investigation into bent vaccine needles and caps

The Authority said it has “reviewed and accepted” the actions that the manufacturer has put in place to deal with the issue.

The Medical Independent (MI) first reported the establishment of the investigation in January of this year. The issue was originally raised at the October 2014 board meeting of the HPRA, minutes of which were seen by the MI under a Freedom of Information request.

“The Marketing Authorisation Holder, Abbott Healthcare Products Ltd, confirmed that actions have been put in place at the manufacturing site, to address the incidence of bent needles,” the Authority spokesperson confirmed this month.

The investigation was initiated in October 2014 and concluded in September this year.

In January, the HPRA told MI that it “assessed the defect as not likely to cause serious harm” and “the defect rate was also low”.

An Authority spokesperson said: “Approximately 30 units were found to be affected by this issue” and that “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.”

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