NEEDLE SPINAL S/SU 22GA 3IN QUINCKE

Additional Manufacturer Narrative

THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. B3 DATE OF EVENT UPDATED-2025 JAN 06.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Description of Event or Problem

MATERIAL # 405171 BATCH # 4201146. VERBATIM: "IN THE PAST WE COULD USE ONE NEEDLE AND SWITCH THE SYRINGE OUT WITH THE THREE INJECTIONS: LIDOCAINE, OMNIPAQUE 300, AND THE STEROID. IT IS BEING REPORTED THAT THEY ARE HAVING ISSUES WITH THE NEEDLE AFTER THE OMNIPAQUE IS INJECTED." CUSTOMER RESPONSE RECEIVED ON 06-JAN-2025. 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? WHAT KIND OF ISSUE THEY WERE FACED? DIFFICULTY ADMINISTERING STEROID THROUGH 25G BD 1.5¿ NEEDLES FOR STEROID JOINT INJECTIONS. I HAVE BEEN USING THESE NEEDLES FOR GREATER THAN ONE YEAR FOR JOINT INJECTIONS. RECENTLY IN THE LAST MONTH, I WILL GET THE NEEDLE IN PLACE, INJECT OMNIPAQUE 300 THROUGH THE NEEDLE TO CONFIRM CORRECT NEEDLE PLACEMENT AND THEN GO TO INJECT THE STEROID AND WILL BE UNABLE TO PUSH ANYTHING THROUGH THE NEEDLE. I HAVE BEEN DOING THE SAME TECHNIQUE WITH THE SAME EQUIPMENT AND THE SAME MEDICATIONS FOR GREATER THAN ONE YEAR. IT WAS JUST OVER THE PAST MONTH OR SO THAT THIS PROBLEM HAS ARISEN. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? APPROXIMATELY FROM THE END OF (B)(6) 2024 TO PRESENT DAY. 3. PLEASE SHARE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE 3209585. 4. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THIS RESULTS IN A LARGER NEEDLE BEING USED THAN NECESSARY AND A SECOND NEEDLE PUNCTURE TO THE JOINT. 5. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES. (B)(6). 6. PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. N/A. CUSTOMER RESPONSE RECEIVED ON 06-JAN-2025. 1. THE LOT NUMBER [3209585] WAS NOT MATCHING FOR MATERIAL NUMBER [405161]. COULD YOU PLEASE CHECK AND RECONFIRM THE LOT NUMBER?

Additional Manufacturer Narrative

INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED AS THE MANUFACTURING RECORDS WERE FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. THE PROCESS FMEA WAS REVIEWED TO EVALUATE POSSIBLE FACTORS AND CONTROLS IN PLACE THAT COULD CONTRIBUTE TO THE REPORTED ISSUES. PER INVESTIGATION PERFORMED, CURRENT CONTROLS ARE ADEQUATE TO MITIGATE RISKS ASSOCIATED TO THE REPORTED FAILURE.

Description of Event or Problem

NO ADDITIONAL INFORMATION.