It was reported that four days post chronic catheter placement, the catheter allegedly leaking liquid from the external part of the catheter.It was further reported that catheter allegedly had no blood return and air was allegedly present in the tubing of the device.Reportedly, the catheter was removed.There was no reported patient injury.
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Date of event was entered as date of explant due to system limitations, since date of event was unknown.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, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2026).
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H10: date of event was entered as date of explant due to system limitations, since date of event was unknown.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 sample was not returned for evaluation, two electronic photos were provided for review.The investigation is inconclusive for the reported issues, as no leaks were noted on the provided photos.A definitive root cause could not be determined based upon the 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: 02/2026).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.H3 other text : device not returned.
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It was reported that approximately two days post chronic catheter placement, the catheter allegedly leaking liquid from the external part of the catheter.It was further reported that that catheter allegedly had no blood return and air was allegedly present in the tubing of the device.Reportedly, the catheter was removed.There was no reported patient injury.
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