ARROW SPINAL ANESTHESIA KIT

Additional Manufacturer Narrative

(B)(4) FULL UDI IS NOT AVAILABLE 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 SPECIFICATIONS ACCORDING TO THE MANUFACTURE'S CERTIFICATE OF ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A POTENTIAL LOT NUMBER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE BUPIVACAINE AMPULE WITH NO EVIDENCE TO SUGGEST A MANUFACTURER-ING RELATED CAUSE. 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.

Description of Event or Problem

IT WAS REPORTED THAT: "SPINAL WENT IN GREAT WITH GREAT RETURN AND RELIEF, 10-20 MIN INTO THE PROCEDURE THE PATIENT STARTED TO FEEL PAIN. ANAESTHESIA GAVE NITROUS, AND KETAMINE, OB DID LOCAL INSTEAD. PLEASE LOOK INTO WHERE THESE TRAYS ARE STORED OR THE TEMP OF THE WAREHOUSE. THE BUPIVACAINE IS TEMP SENSITIVE. WE HAD THE PHARMACY ORDER BUPIVACAINE SEPARATELY. WE HAVE HAD NO INCIDENTS WITH THE INDIVIDUAL VIALS."

Additional Manufacturer Narrative

(B)(4) FULL UDI IS NOT AVAILABLE AS THE LOT# WAS NOT PROVIDED BY THE CUSTOMER.

Description of Event or Problem

IT WAS REPORTED THAT: "SPINAL WENT IN GREAT WITH GREAT RETURN AND RELIEF, 10-20 MIN INTO THE PROCEDURE THE PATIENT STARTED TO FEEL PAIN. ANAESTHESIA GAVE NITROUS, AND KETAMINE, OB DID LOCAL INSTEAD. PLEASE LOOK INTO WHERE THESE TRAYS ARE STORED OR THE TEMP OF THE WAREHOUSE. THE BUPIVACAINE IS TEMP SENSITIVE. WE HAD THE PHARMACY ORDER BUPIVACAINE SEPARATELY. WE HAVE HAD NO INCIDENTS WITH THE INDIVIDUAL VIALS."