ARROW SPINAL ANESTHESIA KIT
Received Mar 12, 2025 · Event occurred Feb 7, 2025
Report 9680794-2025-00189 · MDR key 21581789
Device
Generic name
Needle, Conduction, Anestheti
Manufacturer
Arrow International LlcCatalog number
ASA-25090-SB
Lot number
APG312
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT: "SPINAL BUPIVACAINE SEEMS TO HAVE WORN OFF EARLIER THAN EXPECTED. THE PROCEDURE WAS CONVERTED TO GENERAL ANESTHESIA AND NO ADDITIONAL KITS WERE USED. THERE WAS NO REPORTED PATIENT HARM. "
Additional Manufacturer Narrative
QN# (B)(4). FULL UDI NOT AVAILABEL AS THE LOT# WAS NOT PROVIDED BY THE CUSTOMER. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE POTENCY OF BUPIVACAINE MEETS THE REQUIREMENTS AS PER THE PRODUCT QUALITY SPECIFICATIONS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.
Additional Manufacturer Narrative
QN#(B)(4). FULL UDI NOT AVAILABELA S THE LOT# WAS NOT PROVIDED BY THE CUSTOMER.
Description of Event or Problem
IT WAS REPORTED THAT: "SPINAL BUPIVACAINE SEEMS TO HAVE WORN OFF EARLIER THAN EXPECTED. THE PROCEDURE WAS CONVERTED TO GENERAL ANESTHESIA AND NO ADDITIONAL KITS WERE USED. THERE WAS NO REPORTED PATIENT HARM. "