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
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 10/18/2022 |
Event Type
malfunction
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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: 07/2023).
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Event Description
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It was reported that during a port placement procedure, the tab of the peel apart sheath allegedly broke.It was further reported that the sheath allegedly did not peel completely.There was no reported patient injury.
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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: one fully peeled 8.0fr peel-apart sheath was returned for evaluation.Gross visual evaluation was performed.The investigation is confirmed for the reported sheath broken and did not peel completely and identified material separation, improper valve separation issue as bends and twists were noted throughout the fully peeled 8.0fr peel-apart sheath shafts.T-handle from one fully peeled sheath shaft was noted to be detached.Further, one t-handle from one fully peeled sheath shaft was noted to be detached and the airguard valve did not break properly in the middle.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.D4 (expiry date: 07/2023).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.
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Event Description
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It was reported that during a port placement procedure, the tab of the peel apart sheath allegedly broke.It was further reported that the sheath allegedly did not peel completely.The procedure was completed using the same device.There was no reported patient injury.
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Search Alerts/Recalls
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