C.R. BARD, INC. (BASD) -3006260740 POWERPORT VUE, ISP, MR, 8FR, MICRO; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1608052 |
Device Problems
Difficult to Flush (1251); Device Appears to Trigger Rejection (1524); Blocked Connection (2888)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 03/2016).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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Event Description
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It was reported that approximately eight to ten years post port placement, the port was allegedly difficult to be accessed.It was further reported that the patient allegedly experienced fibrin sheath formation.The current status of the patient is unknown.
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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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.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.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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Event Description
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It was reported that approximately eight to ten years post a port placement, the port was allegedly difficult to be accessed.It was further reported that the port was very difficult to be accessed and sometimes with no access, and used heparin with every other syringe to flush.Reportedly, the patient allegedly experienced fibrin sheath formation.The current status of the patient is unknown.
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Search Alerts/Recalls
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