Catalog Number JP-17702-C |
Device Problem
Air Leak (1008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/21/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device (catalog#) is not intended for sale in the us.Similar device sold in the us.
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Event Description
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It was reported that when a user attempted to puncture in the patient using a needle.Air leak from needle.Sample was discarded.As a result, a new kit was opened for patient use.
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Event Description
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It was reported that when a user attempted to puncture in the patient using a needle.Air leak from needle.Sample was discarded.As a result, a new kit was opened for patient use.
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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.
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Search Alerts/Recalls
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