C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1806060J |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified has not been cleared in the us but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products are identified.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.
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Event Description
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It was reported that approximately one year and one month post port placement procedure, the device allegedly had a fluid leak from the needle insertion site.It was further reported that the port septum was allegedly damaged and the port system 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 isp m.R.I.Implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport mri isp implantable port attached to a groshong catheter was returned for evaluation.Gross, microscopic visual, tactile and functional testing were performed.The investigation is confirmed for port base puncture hole and fluid leak as a leak was observed from a small pinhole on the bottom of the port body and a longitudinal split was also noted on the port septum.Furthermore, a kink was noted on the attached catheter approximately 10.2cm from the distal end of the cath-lock were considered to be an incidental findings since it was not related to the original reported event.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.H11: section a through f ¿ the information provide 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 approximately one year and one month post port placement procedure, the device allegedly had a fluid leak from the needle insertion site.It was further reported that the port septum was allegedly damaged and the port system was removed.There was no reported patient injury.
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Search Alerts/Recalls
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