Model Number IPN045632 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2022 |
Event Type
malfunction
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Event Description
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Reported issue: we received notification from our anesthesiologists that the patients are not setting up; there is bad bupivacaine.
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Manufacturer Narrative
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(b)(4).The kits have not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.The manufacturer of the bupivacaine provided a certificate of analysis for these medication lots and the potency test result reported was 99.8% & 99.2% respectfully, which meets the release specifications of 93.0-107.0% 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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Event Description
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Reported issue: we received notification from our anesthesiologists that the patients are not setting up; there is bad bupivacaine.
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Search Alerts/Recalls
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