BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 10864991 · Received November 18, 2020

    Report

    Report Number
    1920898-2020-01590
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 27, 2020
    Report Date
    January 20, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/3/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 3/10CC, 6MM SYRINGE. CUSTOMER STATES THAT THE PLUNGER CAP LOOKED SMASHED/DEFORMED THAT THE FLAT PIECE ON THE END OF THE PLUNGER CAME LOOSE AND BROKE OFF DURING THE INJECTION. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A CRUSHED PLUNGER CAP. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0083503 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. EXAMINATION OF THE PHOTO INDICATES THAT THE PLUNGER HEAD WAS NOT ATTACHED TO THE PLUNGER AND MINIMAL DAMAGE TO THE CAP COLLAR. THE ENTIRE CAP WAS NOT PRESENT IN THE PHOTO TO INDICATE THE LEVEL OF DAMAGE. IT DID NOT APPEAR TO BE ANY DAMAGE TO THE END OF THE BARREL WHERE THE PLUNGER IS EXTENDED FROM. ROOT CAUSE: MAINTENANCE DISPATCH (L2L) WAS REVIEWED, AND A DISPATCH WAS OPENED FROM 18MAY2020 THRU 20MAY2020 THAT WOULD CAUSE A POSSIBLE BROKEN PLUNGER COMPONENT. L2L #97524 WAS CREATED FOR BENT PLUNGERS AND FIRST INSPECTION DIAL NOT KICKING OFF SYRINGES AT THE EXIT CHUTE. CORRECTION: ADJUSTED THE PLUNGER GUIDE AND RAMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG EXPERIENCED PRODUCT DAMAGE WHILE STILL CONSIDERED OPERABLE AND A BROKEN THUMB PRESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HAVING ONE SYRINGE WITH THE PLUNGER CAP SMASHED/LOOKS DEFORMED. STATED THE FLAT PIECE ON THE END OF THE PLUNGER THAT YOU HOLD TO DRAW BACK, CAME LOOSE AND BROKE OFF DURING INJECTION. CONSUMER HAS PREVIOUS COMPLAINT FILES, DECLINED PRODUCT REPLACEMENT VOUCHER. LOT # 0083503. CAT # 324909. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG EXPERIENCED PRODUCT DAMAGE WHILE STILL CONSIDERED OPERABLE AND A BROKEN THUMB PRESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HAVING ONE SYRINGE WITH THE PLUNGER CAP SMASHED/LOOKS DEFORMED. STATED THE FLAT PIECE ON THE END OF THE PLUNGER THAT YOU HOLD TO DRAW BACK, CAME LOOSE AND BROKE OFF DURING INJECTION. CONSUMER HAS PREVIOUS COMPLAINT FILES, DECLINED PRODUCT REPLACEMENT VOUCHER. LOT # 0083503, CAT # 324909, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330551 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 0083503 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1