C.R. BARD, INC. (BASD) -3006260740 HICKMAN PORT SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0603880C |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified in has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products are identified.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.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2024).
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Event Description
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It was reported that during preparation of a port placement procedure, the peel away sheath allegedly fractured.There was no patient contact.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation.Three electronic photos were provided for review.The investigation is confirmed for the reported sheath tip fracture issue, as the tip of the dilator was 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.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 peel away sheath allegedly fractured.The procedure was completed using another device.There was no patient contact.
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Search Alerts/Recalls
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