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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAYS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAYS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number NEPI-49661C-25
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2018
Event Type  malfunction  
Event Description
Information was received that the bupivacaine in smiths medical spinal single shot tray was ineffective. It was reported to not be anesthetizing the patient and as a result, have had to put the patient to sleep. No patient injury resulted.
 
Manufacturer Narrative
One sealed portex spinal single shot tray was returned for evaluation. Visual evaluation of the bupivacaine-marcaine ampule from the returned tray found no visible non-conformities. 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, performed by the supplier prior to release of bupivacaine was within specification. Review of the sterilization certificate for the tray revealed that the product was processed according to validated specification requirements and parameters. The customer complaint could not be confirmed.
 
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Brand NamePORTEX® SPINAL ANESTHESIA TRAYS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7720175
MDR Text Key115064499
Report Number3012307300-2018-02922
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2020
Device Catalogue NumberNEPI-49661C-25
Device Lot Number3624028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

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