Catalog Number CDC-42802-XP1A |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Event Description
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It was reported that: when they are dilating a vessel the tissue dilator tip is "shredding" and warps at the tip.There is no separation of the device and no harm to the patient.Another kit is opened to resolve.Associated complaints: 9680794-2024-00266 and 9680794-2024-00265.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Qn # (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported that: when they are dilating a vessel the tissue dilator tip is "shredding" and warps at the tip.There is no separation of the device and no harm to the patient.Another kit is opened to resolve.Associated complaints: 9680794-2024-00266, 9680794-2024-00267 and 9680794-2024-00265.
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Search Alerts/Recalls
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