BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM 10BAG 500 AP

    MDR report key: 11730169 · Received April 27, 2021

    Report

    Report Number
    1920898-2021-00469
    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
    PMA / PMN Number
    NA
    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 1ST RELATED COMPLAINT FOR FOREIGN MATTER ON NEEDLE TIP ON LOT # 0132186. INVESTIGATION SUMMARY: CUSTOMER RETURNED (192) LOOSE 3/10CC, 6MM SYRINGES. CUSTOMER STATES THAT THERE WAS A LIQUID CONDENSATION AT THE TIP OF THE NEEDLE. ALL RETURNED SYRINGES WERE TESTED AND 2 OUT OF 5 SAMPLES EXHIBITED A CLEAR DROPLET OF MATERIAL COMING OUT OF THE CANNULA 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 # 0132186 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED 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 #324900 AND LOT #0132186; 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 0132186 WAS REVIEWED. THE SYRINGES WERE ASSEMBLED FROM 11JUL2020 TO 12JUL2020. 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 THAT WOULD CAUSE EXCESSIVE LUBRICANT. ROOT CAUSE: DHR, L2L DISPATCHES, LOGBOOK ENTRIES WERE LOOKED AT, NOTHING WAS FOUND PERTAINING TO THIS DEFECT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 SYRINGE 0.3ML 31GA 6MM 10BAG 500 AP 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 AND THE PRINTING OF SYRINGE SCALE MARK WAS SOMETHING WRONG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631540 SYRINGE 0.3ML 31GA 6MM 10BAG 500 AP PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0132186

    Patients

    Seq Age Sex Outcome Treatment
    1