BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG

    MDR report key: 11734969 · Received April 27, 2021

    Report

    Report Number
    1920898-2021-00472
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 13, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR FOREIGN MATTER ON NEEDLE TIP ON LOT # 0083507. INVESTIGATION SUMMARY: CUSTOMER RETURNED (9) 3/10CC, 6MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 0083507. CUSTOMER STATES THAT THERE WAS A LIQUID CONDENSATION AT THE TIP OF THE NEEDLE. ALL RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A CLEAR DROPLET OF MATERIAL COMING OUT OF THE BARREL WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0083507 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200884826, 200884828] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE 21APR2021, HOLDREGE RECEIVED A PHOTO COMPLAINT FROM MATERIAL #324910 AND LOT #0083507; SYRINGE 0.3ML 31GA 6MM. INITIAL EVALUATION: EXAMINATION OF THE PHOTO INDICATES THAT THE CANNULA HAS A CLEAR DROPLET EXPELLED FROM THE OUTER TIP OF THE CANNULA. THE STOPPER IS SEATED AGAINST THE BARREL SO THERE IS NO EVIDENCE OF EXCESSIVE LUBRICANT AS WOULD BE EVIDENCED BY ¿POOLING¿ INSIDE THE BARREL. THE LAB DID DETERMINE THE LIQUID TO BE DC SILICONE WHICH IS USED TO LUBRICATE THE INSIDE OF THE BARREL TO ALLOW THE PLUNGER TO MOVE WITH EASE AT THE TIME OF USE BY THE CUSTOMER. MANUFACTURING EVALUATION: A REVIEW OF THE SYRINGE ASSEMBLY LINE WHERE THE SYRINGE IN QUESTION WAS PRODUCED WAS COMPLETED. DEVICE HISTORY RECORD; L2L AND LOGBOOK EVALUATION: THE DEVICE HISTORY (DHR) FOR BATCH 0083507 WAS REVIEWED. THE SYRINGES WERE ASSEMBLED FROM 20MAY2020 THRU 23MAY2020. DURING THE MANUFACTURING PROCESS, THE FOLLOWING INSPECTIONS ARE COMPLETED ON REGULAR INTERVALS: VISUAL INSPECTION (WITHOUT AID) EVERY 2 HOURS: EXCESSIVE BARREL LUBRICANT AS EVIDENCED BY ¿POOLING¿ OR FORMATION OF DROPLETS VISUAL INSPECTION EVERY 2 HOUR: BARREL LUBRICANT SHALL BE ON THE INSIDE SURFACES OF THE SYRINGE ONLY IF A DEFECT IS FOUND DURING AN INSPECTION A QUALITY NOTIFICATION IS INITIATED. NOTIFICATIONS WERE REVIEWED, AND NO NONCONFORMANCES WERE NOTED FROM 20MAY2020 THRU 23MAY2020 THAT WOULD CAUSE EXCESSIVE LUBRICANT. ROOT CAUSE: MAINTENANCE DISPATCH (L2L) #97787 WAS CREATED ON 23MAY2020 FOR EXCESSIVE SILICONE BEING PUT IN THE BARRELS. SILICONE BUILDUP IN A PROBE/GUN CAN MINIMIZE THE FLOW OF SILICONE IN THAT PROBE THUS FORCING ADDITIONAL SILICONE INTO THE REMAINING GUNS. CORRECTIVE ACTION: PURGED ALL 9 SILICONE GUNS ON THE LUBRICATION DIAL. VERIFIED THE LUBRICATION DIAL WILL STOP WHEN IT GOES OUTSIDE THE LUBRICATION CONTROLS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 9 SYRINGE 0.3ML 31GA 6MM HALF UNIT 10BAG HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE PATIENT STATED THAT THERE WAS A LIQUID CONDENSATION AT THE TIP OF THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631223 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 0083507 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1