Catalog Number NEPI-49661-25 |
Device Problems
Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
Pain (1994)
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Event Date 08/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluation in progress.
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Event Description
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It was reported that the bupivacaine was not working again on the patient who was giving birth.The patient experienced a lot of pain during the delivery and had to be put under anesthesia.No further complications were reported in connection with this incident.
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Manufacturer Narrative
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Two originally sealed portex® single shot epidural trays were returned for analysis.No visible non-conformities were found during visual evaluation.The drug liquid was found to be clear (colorless) with no particulates visible inside the vials.Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.Assay testing was found to be within specification.A review of the sterilization certificate was reviewed and found within specification.Records were reviewed and deemed adequate.Based on the evidence, the root cause is unknown as the complaint is not confirmed.
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Search Alerts/Recalls
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