C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER
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Model Number 006173P |
Device Problems
Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
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Patient Problems
Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2021 |
Event Type
Injury
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Event Description
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It was reported that the temporary pacing electrode catheter was kinked.The patient was exposed to hazardous, blood, or bodily fluids.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the temporary pacing electrode catheter was kinked.The patient was exposed to hazardous, blood, or bodily fluids.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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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The reported event is confirmed, cause unknown.The used temporary pacing electrode catheter with attached luer syringe was returned without the original packaging.No kink was noted, however, the tip of the electrode catheter was observed to be slightly bent; this is out of specifications.Though a specific cause cannot be determined, a potential root cause for this event could be, "pulling distal wire to taut at mp5898 (assemble electrodes proximal/distal)".No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and states the following: the temporary pacing electrode catheter information for use,baw5014753 revision 6, was reviewed and found to be adequate as it states: "excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires." "inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged." "visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage." 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: the actual/suspected device was inspected.
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Event Description
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It was reported that the temporary pacing electrode catheter was kinked.The patient was exposed to hazardous, blood, or bodily fluids.
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Search Alerts/Recalls
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