H10: 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.The investigation of the reported event is currently underway.H10: d4 (expiration date: 11/2025).H11: section a through f ¿ the information provided by bd represents all 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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H10: as this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of five for this event.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.Additionally, sterilization records were reviewed and this lot met all sterilization release criteria.Investigation summary: five presto devices were returned for evaluation.The devices were all received in a presto white shipping box.Damage to the shipping box was noted, however this appeared to be a result of shipping.No contamination or discoloration was noted to the white shipping box.The devices were removed from the box, and no evidence of contamination was noted to the device trays or sterile barrier.No contamination was seen on the physical devices.The seals of all 5 samples were noted to be intact and correctly sealed.Therefore, the investigation is unconfirmed for the contamination and unsealed packaging, as no evidence of contamination or damage to the sterile barrier to the returned devices.The definitive root cause for the reported contamination and unsealed packaging could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 11/2025), g3, h6 (method).H11: section a through f ¿ the information provided by bd represents all 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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