Model Number 006173P |
Device Problem
Deformation Due to Compressive Stress (2889)
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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 unconfirmed as the problem could not be reproduced.The temporary pacing electrode with luer syringe was returned without the original packaging.No kinks or visible deformities were noted on the surface of the device; which is within specifications.As the reported event is unconfirmed, a dhr review is not required.As the reported event is unconfirmed, a label/packaging review is not required.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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