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, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 09/2024).
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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: the physical device was not returned for evaluation but two electronic photos were reviewed.The first photo shows a cannula hub within the packaging.However, a package seal cannot be determined.A hair strand is noted to be present next to the cannula hub.The second photo shows the label of the magnum needle.Provided label matches with the reported details lot number (refx3251) and catlog number (mn1416).While a hair strand can be noted next to the needle, a complete view of the packaging and package seal was not provided for complete evaluation.Therefore, based on the photo review foreign material in packaging cannot be confirmed.A definitive root cause for the alleged foreign material could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 09/2024), g3, h6 (method).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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