BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 20 ML SYRINGE

    MDR report key: 8800268 · Received July 17, 2019

    Report

    Report Number
    3003152976-2019-00472
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    July 4, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903006138
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE PHOTOS WERE PROVIDED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, RED ADHESIVE TAPE IS OBSERVED ON THE BLISTER PACKAGING. A DEVICE HISTORY REVIEW FOR LOT 1905288 DID NOT REVEAL ANY ANNOTATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS RELATED TO THIS ISSUE. THIS ADHESIVE TAPE IS USED DURING THE PACKAGING PROCESS WHEN THE PAPER ROLL IS REPLACED, ADHERING THE LAST METER OF TAPE TO THE NEW ROLL. THERE IS A DETECTOR IN THE PACKAGING MACHINE TO IDENTIFY THIS PORTION OF MATERIAL AND AUTOMATICALLY REJECT TO SCRAP WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED DE TO A FAILURE IN EITHER THE DETECTION SYSTEM OR THE REJECTION SYSTEM THAT SENDS THE TAPED PORTION TO SCRAP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 20 ML SYRINGE PACKAGE WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PACKAGING WAS DAMAGED (TORN AND TAPED) UPON RECEIPT OF THE PRODUCT, WHICH NO LONGER ENSURES THE STERILITY OF THE SYRINGES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ 20 ML SYRINGE PACKAGE WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PACKAGING WAS DAMAGED (TORN AND TAPED) UPON RECEIPT OF THE PRODUCT, WHICH NO LONGER ENSURES THE STERILITY OF THE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592748 BD PLASTIPAK 20 ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1905288 30382903006138

    Patients

    Seq Age Sex Outcome Treatment
    1 Other