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
Restricted Flow rate (1248); Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2023 |
Event Type
malfunction
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Event Description
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It was reported that one month and seven days post a port placement via the right upper arm, the port allegedly had a flow problem.It was further reported that fibrin sheath was suspected on imaging and the catheter was not used for a while.Afterwards, when the catheter was used, there was an alleged chemical leak.Reportedly, the catheter was removed.There was no reported patient injury.
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Manufacturer Narrative
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H10: 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.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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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Manufacturer Narrative
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H10: 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.H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one powerport implantable port attached to a catheter in two segments was received for evaluation.Gross, visual, tactile and functional testing were performed.A split was noted to the port septum.The edges of the complete circumferential break on the distal end of the attached catheter and the proximal end of the distal catheter segment were noted to be uneven.The surfaces were noted to be granular.Therefore, the investigation is confirmed for the reported fluid leak and identified fracture, material separation, material split.However, the investigation is inconclusive for the reported flow problem as the exact circumstance at the time of the event reported event was unknown.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (device) h11: h6 (method, result, conclusion) 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.H3 other text : see h10.
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Event Description
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It was reported that one month and seven days post a port placement via the right upper arm, the port allegedly had a flow problem.It was further reported that fibrin sheath was suspected on imaging and the catheter was not used for a while.Afterwards, when the catheter was used, there was an alleged chemical leak.Reportedly, the catheter was removed.There was no reported patient injury.
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Search Alerts/Recalls
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