C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1616070 |
Device Problems
Entrapment of Device (1212); Difficult to Insert (1316); Defective Component (2292); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2022 |
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: 05/2023).
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Event Description
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It was reported that during preparation of a port placement procedure, the trocar allegedly damaged.The procedure was completed by using another device.There was no patient contact.
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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 6.5fr peel-apart sheath and vessel dilator and one 5f dilator were returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported defective peel apart sheath issue as the distal tip of both the peel-apart sheath and vessel dilator were noted to be fractured.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.H10: d4(expiry date: 05/2023).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 during preparation of a port placement procedure, the trocar allegedly damaged.The procedure was completed by using another device.There was no patient contact.
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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 6.5fr peel-apart sheath and vessel dilator and one 5f dilator were returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is inconclusive for the reported defective peel apart sheath, entrapment of device and difficult to insert issue as the exact circumstance at the time of the event was not verified.The investigation is confirmed for the identified deformation issue as distal tip of both the peel-apart sheath and vessel dilator were noted to be deformed.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.H10: d4(expiry date: 05/2023),.
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Event Description
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It was reported that during preparation of a port placement procedure, the trocar was allegedly damaged.The procedure was completed by using another device.There was no patient contact.
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Search Alerts/Recalls
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