C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASULAR
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Model Number 5618000 |
Device Problems
Fracture (1260); Material Separation (1562); Separation Failure (2547); Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/10/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a port placement procedure, the valve on the peel away sheath was allegedly broken into pieces when pulling in apart.It was further reported that the pieces were completely detached from the valve.There was no reported patient 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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 11/2023).
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Manufacturer Narrative
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Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one fully peeled 8.0fr peel-apart sheath was returned for evaluation.Gross visual evaluation was performed.The investigation is confirmed for the reported difficulty in peeling the introducer sheath and identified improper valve separation issue as bends and twists were noted on 8.0fr peel-apart sheath segments.Further, the airguard valve did not break properly in the middle.However, the investigation is inconclusive for the material separation issue as the exact circumstances at the time of the reported event cannot be verified, and the reported event could not be reproduced in the lab.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.
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Event Description
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It was reported that during a port placement procedure, the valve on the peel away sheath allegedly had a difficulty in separation.It was further reported that the device, broken into pieces when pulling in apart.There was no reported patient injury.
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Search Alerts/Recalls
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