Catalog Number NLD-15597-20 |
Device Problem
Failure to Infuse (2340)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Event Description
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Information was received indicating that a smiths medical portex® spinal anesthesia needle was placed successfully.However, it was reported to not be working.Placement was checked by different staff and was noted to be placed correctly.To manage patient discomfort, a secondary route was used.There were no reported adverse effects.
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Manufacturer Narrative
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One bupivacaine ampule, one lidocaine ampule, and one epinephrine ampule were returned from a portex® spinal anesthesia tray.Visual evaluation of the ampules found no visible non-conformities.The drug liquid was found to be clear (colorless) with no particles visible inside the vials.Review of the device history records, incoming records, and sterilization records found no discrepancies or anomalies.Assay testing performed by the supplier prior to release of the anesthetics were within specification for the drug lot numbers.The anesthetics are supplied items and the complaint notification was forwarded to the supplier.Based on available information and evidences, no product quality problem could be confirmed.The root cause is unconfirmed as no fault could be found.
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Manufacturer Narrative
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Additional information: potential event dates: (b)(6) 2017; potential lot numbers: 3373455, 3371993, 3468284, 3455343.
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Event Description
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Due to the intubation, the reporter noted that the patient had increased risk of newborn respiratory failure.The reporter was unaware of any complication with the newborn.
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Search Alerts/Recalls
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