C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8 FR. GROSHONG, INT W SP, ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8808560 |
Device Problems
Difficult to Flush (1251); Fracture (1260); Material Separation (1562); Blocked Connection (2888)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2024 |
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 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 (expiry date: 10/2024).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 approximately three months post port placement procedure, port allegedly unable to be accessed.It was also reported that the catheter was allegedly unable to be flushed.It was further reported that the port allegedly fractured and the distal segment was removed via percutaneous access using snare.Reportedly, the port was removed and replaced.There was no reported patient injury.
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Search Alerts/Recalls
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