NEEDLE SPINAL S/SU 22GA 2-1/2IN QUINCKE

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.

Description of Event or Problem

MATERIAL # 405074 BATCH # 4166281. WE HAVE HAD SEVERAL REPORTED EVENTS OF LEAKING WHEN USING THIS SYRINGE WITH A LUER SPINAL NEEDLE (ITEM 405074 22G X 2.5IN QUINCKE NEEDLE) TO ADMINISTER INTRATHECAL CHEMOTHERAPY. THIS IS CAUSING CONCERN DUE TO HAZARDOUS DRUG EXPOSURE AND THE RISK THAT A PATIENT WON¿T RECEIVE THE FULL AMOUNT OF CHEMOTHERAPY.

Description of Event or Problem

ADDITIONAL INFORMATION: FOR CLARITY, THIS LEAKING HAS BEEN REPORTED MULTIPLE TIMES. ONLY ONE NEEDLE AND SYRINGE SET WAS SAVED FROM AN EXACT EVENT, BUT I HAVE MULTIPLE OTHER SAMPLES OF PRODUCTS NOT USED ON A PATIENT BUT COMING FROM THE SAME LOT NUMBERS. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THE PATIENT DID NOT RECEIVE THE FULL DOSE OF CHEMOTHERAPY BUT WAS UNHARMED COULD YOU PLEASE CONFIRM IF SYRINGE LOT 4078418 IS ALSO EXPERIENCING LEAKAGE ISSUES? LEAKS HAVE BEEN REPORTED WITH MULTIPLE SIZES OF SPINAL NEEDLES AND IT IS UNKNOWN IF ALL THESE SYRINGES WERE FROM THE SAME LOT DURING THESE EVENTS. COULD YOU PLEASE SPECIFY THE EXACT LOCATION WHERE THE LEAK OCCURRED ON THE PRODUCT? LEAKING OCCURS FROM THE HUB OF THE SPINAL NEEDLE, AROUND THE SLIP-TIP SYRINGE. CLINICIANS STATE THAT THEY HAVE TO FORCEFULLY PRESS THE SLIP TIP SYRINGE INTO THE HUB OF THE NEEDLE TO PREVENT LEAKING, AND THAT THIS AMOUNT OF FORCE IS GREATER THAN THEY HAVE HAD TO USE TO ACHIEVE A SECURE CONNECTION PRIOR TO THESE EVENTS. I HAVE NUMEROUS SAMPLES. I DO NOT KNOW THE LOT NUMBERS OF THE SPECIFIC ITEMS THAT WERE USED AND SAVED FROM PATIENT CARE. THIS SAMPLE IS ALSO CONTAMINATED WITH HAZARDOUS DRUG. PLEASE CONFIRM IF THE PRODUCTS WITH HAZARDOUS DRUG CAN BE RETURNED AND WHETHER ALL SAMPLES CAN BE RETURNED IN THE SAME SHIPPING BOX/LABEL.

Additional Manufacturer Narrative

SIX 22GA NEEDLES WITH LOT NUMBERS 2129330, 2334748, AND 4166281 WERE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE NEEDLES HAD ALL THEIR COMPONENTS ONE NEEDLE, ONE STYLET AND A SHIELD. NO DEFECTS OR ISSUES OBSERVED ON THE NEEDLES. FUNCTIONAL, AND DIMENSIONAL CHARACTERISTICS WERE PERFORMED. ALL TEST PERFORMED WERE FOUND WITHIN SPECIFICATION REQUIREMENTS, NO LEAK OBSERVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. IT IS RECOMMENDED TO USE SYRINGES COMPATIBLE WITH ISO STANDARDS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.