ARROW SPINAL ANESTHESIA KIT
Received Oct 7, 2024 · Event occurred Sep 3, 2024
Report 9680794-2024-01021 · MDR key 20381709
Device
Generic name
Needle, Conduction, Anestheti
Manufacturer
Arrow International LlcCatalog number
ASA-25090-SB
Lot number
33F24C0030
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
NA · Unknown
- Inadequate Pain Relief
- Insufficient Information
- Inadequate Pain Relief
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT: "BUPIVACAINE INCLUDED WITH SPINAL TRAY WAS INEFFECTIVE. 6 PATIENTS HAD TO BE TRANSITIONED TO GENERAL ANESTHESIA DUE TO PATIENTS MOVING AND RESPONDING DURING PROCEDURE. PT'S WERE UNDERGOING TOTAL HIP/TOTAL KNEE REPLACEMENTS." ASSOCIATED COMPLAINTS: 9680794-2024-01025, 9680794-2024-01024, 9680794-2024-01023, 9680794-2024-01022.
Description of Event or Problem
IT WAS REPORTED THAT: "BUPIVACAINE INCLUDED WITH SPINAL TRAY WAS INEFFECTIVE. 6 PATIENTS HAD TO BE TRANSITIONED TO GENERAL ANESTHESIA DUE TO PATIENTS MOVING AND RESPONDING DURING PROCEDURE. PT'S WERE UNDERGOING TOTAL HIP/TOTAL KNEE REPLACEMENTS." ASSOCIATED COMPLAINTS: 9680794-2024-01025, 9680794-2024-01024, 9680794-2024-01023, 9680794-2024-01022, AND 968 0794-2024-01012.
Additional Manufacturer Narrative
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE POTENCY OF BUPIVACAINE IS WITHIN THE SPECIFIED REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE BUPIVACAINE AMPULE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.