BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 9317287 · Received November 13, 2019

    Report

    Report Number
    1213809-2019-01139
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    March 21, 2019
    Report Date
    December 6, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN IDENTIFIED AS A DUPLICATE OF MFR REPORT #: 1213809-2019-01138, THEREFORE THIS MDR SHOULD BE DISREGARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 44 SYRINGE 10ML LL BNS EXPERIENCED LIGHT SCALE MARKINGS WHICH WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301029 BATCH NO: 9080611, UNKNOWN. EVENT DESCRIPTION: I AM CONTACTING YOU REGARDING YOUR P/N 301029. WE RECEIVED FROM ONE OF OUR BIGGER ACCOUNTS FOR THIS PART A COMPLAINT. THE LAST 3 ORDERS THEY RECEIVED FROM MARCH TO JULY OF 2019 FOR (B)(4) EACH THEY FOUND SYRINGES WITH BLURRED GRADUATION LINES. THE SYRINGES SENT TO OUR CUSTOMER WERE FROM YOUR LOT NOS.: 9080611: OF 1,076 PCS THEY FOUND 29 DEFECTED ONES. UNKNOWN LOT OF 2,485 THEY FOUND 15 DEFECTED ONES

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9080611, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-03-21; MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 44 SYRINGE 10ML LL BNS EXPERIENCED LIGHT SCALE MARKINGS WHICH WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301029 BATCH NO: 9080611, UNKNOWN. EVENT DESCRIPTION: I AM CONTACTING YOU REGARDING YOUR P/N 301029. WE RECEIVED FROM ONE OF OUR BIGGER ACCOUNTS FOR THIS PART A COMPLAINT. THE LAST 3 ORDERS THEY RECEIVED FROM MARCH TO JULY OF 2019 FOR 2,500 PIECES EACH THEY FOUND SYRINGES WITH BLURRED GRADUATION LINES. THE SYRINGES SENT TO OUR CUSTOMER WERE FROM YOUR LOT NOS.: 9080611: OF 1,076 PCS THEY FOUND 29 DEFECTED ONES. UNKNOWN LOT: OF 2,485 THEY FOUND 15 DEFECTED ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108311 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other