As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2025).
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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: one presto inflation device was returned for evaluation.The device was returned in the packaging.The bottom portion of the tyvek packaging was noted to be unsealed.Evidence of the seal was noted on the packaging.No other anomalies were noted.2 electronic images were also provided for review.The bottom portion of the tyvek sealing is noted to be peeled in both photos.Therefore, the investigation is confirmed for the reported peeling sterile barrier layer.The definitive root cause for the peeling sterile barrier could not be determined based upon available 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 (expiry date: 06/2025), g3, h6 (method).H11: b5, h6 (result, conclusion).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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