inforMED — FDA medical device performance lookup

Device

Generic name

Needle, Conduction, Anestheti

Manufacturer

Arrow International Llc

Catalog number

ASK-24090-SPH

Lot number

33F24C0239

Product problems

Lack of Effect
Lack of Effect

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: "LAST WEEK WE HAD TWO DIFFERENT ANESTHESIA PROVIDERS HAVE ISSUES W/ SPINALS NOT WORKING AND THEY BELIEVE IT WAS THE DRUGS IN THE KIT.' I SPOKE WITH OUR CHIEF OF ANESTHESIA, AND HE CONFIRMED THAT THE BUPIVACAINE HAD NO EFFECT ON THE PATIENTS, AND THE KITS THEMSELVES WERE FINE." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPROTED AS FINE PSOT THE PROCEDURE. ASSOCIATED COMPLAINTS: 9680794-2025-00402 AND 9680794-2025-00403.

Additional Manufacturer Narrative

(B)(4). 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.