Catalog Number ASK-05500-KPR |
Device Problem
Break (1069)
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Patient Problem
Not Applicable (3189)
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Event Date 06/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).The investigation report for the returned device has not been submitted at this time.The manufacturer will continue to monitor and trend related events.
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Event Description
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When the kit was opened, the vial was broken.There were no reported injuries.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the kit and the saline ampule with no relevant findings.The customer reported an ampule was broken upon opening a kit.The customer returned one saline solution ampule broken into two pieces for investigation ((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 ((b)(4)).A corrective action is not required at this time as it cannot be determined at what point the saline ampule broke.However, shipping and handling could not be eliminated as potential causes.The reported complaint of a broken ampule was confirmed based upon the sample received.The saline ampule was found to have broken at the score line.No pieces of the ampule were missing.A device history record review was performed on the kit and the saline ampule with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of a broken ampule could not be determined.However, shipping and handling could not be eliminated as potential causes.
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Event Description
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When the kit was opened, the vial was broken.There were no reported injuries.
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Search Alerts/Recalls
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