C.R. BARD, INC. (BASD) -3006260740 HICKMAN PORT SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0603880C |
Device Problems
Device Damaged Prior to Use (2284); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2023 |
Event Type
malfunction
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Event Description
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It was reported that during the preparation of a port placement procedure in the right side of the sixth thoracic vertebra via the left internal jugular vein, after opening the infusion port package for puncture, it was allegedly found that the outer ring of the guidewire was showing signs of falling off, and the operating room was not equipped with an additional puncture kit.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: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 12/2024).H11: section a through f ¿ the information provided 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.H3 other text : device pending return.
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Search Alerts/Recalls
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