Catalog Number ASK-05503-UPM |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that when opening the kit, they noticed the lidocaine bottle was broken in 5 random kits but all having same lot 23f19g0146.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the epidural kit with no relevant findings.The customer reported broken ampules in the kit.The customer returned one opened kit which contained the lidocaine ampule broken into two pieces for investigation (reference files (b)(4)).The ampule was visually examined with and without magnification.Visual examination of the ampule revealed the ampule is broken at the score line.No pieces of the ampule appear to be missing.No other defects or anomalies were observed (reference files (b)(4)).The reported complaint of a broken ampule was confirmed based upon the sample received.The lidocaine ampule was found to have broken at the score line.A device history record review was performed with no relevant findings.Based on the information provided, the potential root cause of this issue is design related.A capa was initiated to further investigate this complaint issue.
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Event Description
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It was reported that when opening the kit, they noticed the lidocaine bottle was broken in 5 random kits but all having same lot 23f19g0146.
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Search Alerts/Recalls
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