C.R. BARD, INC. (BASD) -3006260740 SLIMPORT IMPLANTABLE PORT, DUAL-LUMEN ROSENBLATT, 7F; PORT & CATHETER, IMPLANED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 0604970 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.The investigation of the reported event is currently underway.(expiry date: 05/2024).
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Event Description
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It was reported that during a port placement procedure, the device couldn't attach the catheter to the chamber hub.There was no reported patient injury.
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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.Investigation summary: one slimport d/l rosenblatt attached to a catheter was returned for evaluation.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is inconclusive for the reported loose or intermittent connection issue as the device was returned without cath-lock connected and it is unknown whether cath-lock was connected during the procedure.The definitive root cause 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: 05/2024).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 : see h10.
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Event Description
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It was reported that during a port placement procedure, the device couldn't attach the catheter to the chamber hub.There was no reported patient injury.
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Search Alerts/Recalls
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