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Catalog Number ID4030 |
Device Problems
Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.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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Event Description
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It was reported that prior to an angioplasty procedure, the box of the device was allegedly unsealed.It was further reported that the device was stained with an unknown chemical substance.There was no patient contact.
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Manufacturer Narrative
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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.Additionally, sterilization records were reviewed, and this lot met all sterilization release criteria.Investigation summary: one presto device was returned for evaluation.The device was received in a presto white shipping box.Damage to the shipping box was noted, however this appeared to be a result of shipping.Yellow staining was noted to the outer white yellow shipping box.The device was removed from the box, and the same yellow staining was seen on a portion of the tyvek lid.No contamination was seen on the physical devices inside the tray.The tyvek layer was unsealed and peeled up where the staining was present of the tyvek layer.Ftir and sem/eds analysis was performed on the yellow staining.The results of this testing were compared to manufacturing records, and no match to the material was able to be identified.The source of the staining could not be determined.Therefore, the investigation is confirmed for the reported contamination, as an unknown yellow staining was noted to the outer white shipping box and to the tyvek layer on the device packaging.The investigation is also confirmed for the unsealed packaging, as the sterile barrier was peeled where the staining was present on the tyvek layer.The definitive root cause for the reported contamination and unsealed packaging could not be determined based upon the 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.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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Event Description
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It was reported that prior to an angioplasty procedure, the box of the device was allegedly unsealed.It was further reported that the device was stained with an unknown chemical substance.There was no patient contact.
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Search Alerts/Recalls
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