As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation; however, photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2023).
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: a sample was retuned for evaluation and no anomalies were noted to the device.The returned device was removed from the package but no signs of the foreign material was noted during the evaluation.No further functionality testing was conducted due to the nature of the complaint.One photo was reviewed by quality engineer.The photo shows a hair like foreign material found over the outer surface of the inflation luer, no other anomalies noted.Therefore, based on the photo review, the reported failure foreign material can be confirmed.However, the investigation will be inconclusive for the reported device contamination as there was no signs of the foreign material noted during evaluation although the photo attached was noted for the foreign material.A definitive root cause for the alleged foreign material could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4(expiry date: 08/2023).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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