Catalog Number ASK-05001-SLR1 |
Device Problem
Crack (1135)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
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Event Description
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Per medwatch: it is reported that when the spinal needle was opened it was cracked on the luer lock end.There was no patient injury.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the epidural needles with no relevant findings.The customer reported the luer end of the epidural needle was cracked.The customer returned one epidural needle and lidstock.The returned needle was visually examined with and without magnification.Visual examination of the returned needle revealed that the needle appears typical.Microscopic examination of the needle's hub revealed damaged at the luer end.There appears to be tooling marks as well as a crack.The cannula and cannula's tip does not appear to be used.No other defects or anomalies were observed.Nonconformance have been initiated to further investigate this complaint issue.The reported complaint of the luer end of the epidural needle being damaged was confirmed based on the sample received.Visual examination of the returned needle revealed damage of the hub at the luer end that appears to be tooling marks.The cannula and tip did not appear to be used.A device history record review performed on the epidural needle showed no evidence to suggest a manufacturing other remarks: related cause.The epidural needle is a purchased part.Therefore, the potential root cause of this issue is supplier related.A nonconformance has been initiated to further investigate this issue.
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Event Description
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Per medwatch: it is reported that when the spinal needle was opened it was cracked on the luer lock end.There was no patient injury.
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Search Alerts/Recalls
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