BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM 10BAG 500 AP

    MDR report key: 11734945 · Received April 27, 2021

    Report

    Report Number
    1920898-2021-00471
    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 STOPPER DAMAGED ON LOT # 0132186. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 3/10CC, 6MM SYRINGE. CUSTOMER STATES THAT THE RUBBER STOPPER IS DISTORTED. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A DEFORMED STOPPER IN THE BARREL. 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 08APR2021, HOLDREGE RECEIVED A PHOTO COMPLAINT FROM MATERIAL #324900 AND BATCH #0132186; SYRINGE 0.3ML 31GA 6MM. INITIAL EVALUATION: EXAMINATION OF THE PHOTO INDICATES THAT THE STOPPER LEADING EDGE WAS ANGLED TO ONE SIDE IN THE BARREL AND NOT STRAIGHT ACROSS. 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. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR ISSUES RELATING TO THE ASSEMBLED SYRINGE DEFECT. ROOT CAUSE: MAINTENANCE DISPATCH (L2L) WAS REVIEWED, AND DISPATCH #100951 WAS CREATED ON 11JUL020 FOR STOPPER ISSUES. CORRECTIVE ACTION: CLEANED THE STOPPER RAILS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 6MM 10BAG 500 AP HAD A DEFORMED STOPPER. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "RUBBER STOPPER IS DISTORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630347 SYRINGE 0.3ML 31GA 6MM 10BAG 500 AP PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0132186

    Patients

    Seq Age Sex Outcome Treatment
    1