NEEDLE SPINAL S/SU 22GA 2-1/2IN QUINCKE
Received Nov 21, 2024 · Event occurred Oct 25, 2024
Report 2618282-2024-00167 · MDR key 20745011
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton DickinsonCatalog number
405074
Lot number
4166281
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
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.
Description of Event or Problem
MATERIAL #: 405074; BATCH#: 4166281. IT WAS REPORTED BY CUSTOMER THAT THEY 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.
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.
Description of Event or Problem
NO ADDITIONAL INFORMATION