ARROW SPINAL ANESTHESIA KIT
Received Feb 9, 2026 · Event occurred Jan 12, 2026
Report 9680794-2026-00153 · MDR key 24289533
Device
Generic name
Needle, Conduction, Anestheti
Manufacturer
Arrow International LlcCatalog number
ASA-25090-SB
Lot number
33F25G0098
Product problems
- Lack of Effect
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "CLINICIAN REPORTED THAT FOLLOWING SPINAL PLACEMENT, THE EXPECTED ANESTHETIC EFFECT WAS NOT ACHIEVED AFTER ADMINISTRATION OF BUPIVACAINE WHICH LED TO CONVERSION TO GENERAL ANESTHESIA. THE PATIENT WAS REPORTED AS FINE."
Description of Event or Problem
IT WAS REPORTED THAT "CLINICIAN REPORTED THAT FOLLOWING SPINAL PLACEMENT, THE EXPECTED ANESTHETIC EFFECT WAS NOT ACHIEVED AFTER ADMI NISTRATION OF BUPIVACAINE WHICH LEAD TO CONVERSION TO GENERAL ANESTHESIA. THE PATIENT WAS REPORTED AS FINE."
Additional Manufacturer Narrative
QN# (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE POTENCY OF BUPIVACAINE MEETS SPECIFICATIONS ACCORDING TO THE MANUFACTURER'S QUALITY CHECKS. 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 FOR REPORTS OF THIS NATURE.