C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6CF INT W SP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8806060 |
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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Event Description
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It was reported that during a port placement procedure, 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: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiration date: 07/2024).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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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.H10: d4 (expiration date: 07/2024), g3 h11: b5 h11: device not returned.
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Event Description
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It was reported that during a port placement procedure via the right internal jugular vein, the guidewire was implanted smoothly, but the vascular sheath was allegedly could not be inserted.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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