ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR; CATHETER, HEMODIALYSIS, IMPLA
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Catalog Number CS-15272-VFE |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).
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Event Description
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It was reported on (b)(6) 2022 , "during the regular attempt to use/open the peel away sheath , the "seam" of the sheath did not open.It could not be torn open and thus the catheter did not come out , and the procedure had to be interrupted.This also happened when using another opened pack.No patient was harmed." no medical intervention was needed, and the current patient's condition is fine.Additional information was received on (b)(6) 2022: both products in the complaint was in use on the same patient.Another package was opened and used to complete the procedure.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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It was reported on 17aug2022, "during the regular attempt to use/open the peel away sheath, the "seam" of the sheath did not open.It could not be torn open and thus the catheter did not come out, and the procedure had to be interrupted.This also happened when using another opened pack.No patient was harmed.".No medical intervention was needed, and the current patient's condition is fine.Additional information was received on 05sept2022: both products in the complaint was in use on the same patient.Another package was opened and used to complete the procedure.2 mdrs submitted to capture both events: 9680794-2022-00585.
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Search Alerts/Recalls
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