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
Loose or Intermittent Connection (1371); Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.One electronic video was provided for review.In the video when physician trying to connect the cath lock it was noted extremely loose and not locked in place.Therefore, the investigation is confirmed for the reported fitting problem and loose or intermittent connection issues.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 09/2023).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 a port placement procedure via the right internal jugular vein, the catheter was pushed into a half of the connecting handle, but it allegedly failed to pass through the bulge.It was further reported that the catheter failed to be pulled by the fasteners to cover the entire connecting handle.Reportedly, the fasteners were extremely loose.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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