C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1608062 |
Device Problems
Defective Device (2588); Migration (4003)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2019 |
Event Type
Injury
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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 device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 06/2019).
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Event Description
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It was reported through the litigation process that the port was deployed successfully.At some time later, the port was removed due to non-functional.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 sample was not returned for evaluation; however, a medical record review was performed.The investigation is inconclusive for the reported catheter migration issue as the exact circumstances at the time of reported event was unknown.However, the investigation is confirmed for the defective device issue.According to the medical record, approximately one year and three months post port deployment, the patient presented for mediport removal due to non-functioning.The port was removed successfully from the patient body.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.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 : device not returned.
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Event Description
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It was reported through the litigation process that the port catheter was placed in patient for the purpose of ongoing venous access for diabetes treatment.Approximately one year three months post deployment, it was alleged that the port catheter migrated into the left brachiocephalic vein.At some time later, the port was removed due to non-functional.The current status of the patient is unknown.
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Search Alerts/Recalls
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