C.R. BARD, INC. (BASD) -3006260740 POWERPORT TITANIUM ISP 6CF INT WSP ATT SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8706060 |
Device Problems
Disconnection (1171); Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: 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.H10: d4 (expiration date: 03/2024) 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.
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Event Description
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It was reported that during a port placement procedure via the left internal jugular vein, the guidewire was implanted smoothly, the sheath never entered, and the disconnection was allegedly found that it was impassable.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: additional information was received and the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.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 not returned.
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Event Description
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It was reported that during a port placement procedure via the left internal jugular vein, the guidewire was implanted smoothly, but the sheath core was not smooth and allegedly could not able to enter the blood vessel along the guidewire.The procedure was completed using another device.There was no reported patient injury.
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