C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1716070J |
Device Problems
Fluid/Blood Leak (1250); Reflux within Device (1522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport slim implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f products is identified.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.(expiration date: 04/2023).Device pending return.
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Event Description
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It was reported that approximately nine days post port placement via the subclavian vein, the catheter allegedly leaked subcutaneously.It was further reported that the backflow was confirmed.Reportedly the port removed.There was no reported patient injury.
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Event Description
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It was reported that approximately nine days post port placement via the subclavian vein, the catheter allegedly leaked subcutaneously.It was further reported that the backflow was confirmed.Reportedly the port removed on later days.There was no reported patient injury.
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Manufacturer Narrative
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The catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport slim implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f products is identified in d2 and g4.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 powerport slim implantable port attached to a catheter was returned for evaluation.Gross, microscopic visual, tactile evaluation and functional testing was performed.The investigation is inconclusive for the reported fluid leak and backflow issues as the exact circumstances at the time of the reported event cannot be verified and the sample evaluation results indicating no difficulty under laboratory conditions are not by themselves sufficient to confirm this event occurred under clinical conditions.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.D4 (expiration date: 04/2023).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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