C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1608062 |
Device Problem
Suction Problem (2170)
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Patient Problem
Scar Tissue (2060)
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Event Date 11/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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H10: 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.H10: d4 (expiration date: 03/2022) 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 through litigation process that ten months and nineteen days later post port placement procedure, the patient allegedly had suction problem.It was further reported that the port was freed from scar tissue and removed.However, the current status of the patient is unknown.
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Manufacturer Narrative
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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.Medical records were provided and reviewed.A patient underwent port placement procedure on the right chest wall.A year later, port was removed due to malfunctioning and the patient underwent another port.Angiography showed that contrast could be pushed but no blood could not pull back.The port was taken off and the tubing was pulled out.Four years later, patient had a syncopal episode.After few months, patient presented to emergency department with the complaint of pain from port.Blood cultures are positive for pseudomonas bacteremia.Hence the patient underwent removal of infected port-a-cath.Therefore, the investigation is confirmed for the reported suction problem.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 through litigation process that ten months and nineteen days later post a port placement in the right chest wall, the device allegedly had suction problem as blood could not be pulled back.Reportedly, using a combination of blunt dissection and electric bovie, the port was freed from scar tissue and was removed.However, the current status of the patient is unknown.
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Search Alerts/Recalls
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