BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10CC S/T WOS STERILE WATER BNS

    MDR report key: 10229561 · Received July 3, 2020

    Report

    Report Number
    1213809-2020-00433
    Event Type
    Malfunction
    Date Received
    July 3, 2020
    Date of Event
    June 12, 2020
    Report Date
    July 14, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT HAS BEEN NOTED THAT THIS INCIDENT HAS ALREADY BEEN CAPTURED UNDER COMPLETED MDRS WITH THE FOLLOWING MFR REPORT #S: 1213809-2020-00314, 1213809-2020-00268. THIS SUBMISSION CAN THEREFORE BE DISREGARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10CC S/T WOS STERILE WATER BNS EXPERIENCED SCALE MARKING ISSUES WHICH WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 304086, BATCH NO: 0022961 & 0055331. THE MATERIAL 304086 FOR TWO LOT NUMBERS HAD DEFECTIVE MARKING ON THE SYRINGES. CUSTOMER STATED THE MARKINGS WERE MISSING OR DEFORMED OR UNREADABLE. THE TWO LOT NUMBERS ARE 0022961 & 0055331.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN:  (B)(6) USA HAS BEEN USED AS A DEFAULT.  A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0022961, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-01-22. MEDICAL DEVICE LOT #: 0055331, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-02-24.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10CC S/T WOS STERILE WATER BNS EXPERIENCED SCALE MARKING ISSUES WHICH WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 304086 BATCH NO: 0022961 & 0055331. THE MATERIAL 304086 FOR TWO LOT NUMBERS HAD DEFECTIVE MARKING ON THE SYRINGES. CUSTOMER STATED THE MARKINGS WERE MISSING OR DEFORMED OR UNREADABLE. THE TWO LOT NUMBERS ARE 0022961 & 0055331.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691926 SYRINGE 10CC S/T WOS STERILE WATER BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other