BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10783176 · Received November 4, 2020

    Report

    Report Number
    3003152976-2020-00483
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 12, 2020
    Report Date
    November 10, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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: 11/3/2020. H.6. INVESTIGATION: TWELVE SEALED SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, THE THUMB PRESS IS OBSERVED TO BE BROKEN ON ALL PRODUCT PROVIDED AND THE BROKEN PIECES ARE WITHIN THE SEALED BLISTER PACKAGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2002277, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THE DAMAGE LIKELY OCCURRED DUE TO THE PACKAGES JAMMING DURING MANUFACTURING OR DURING TRANSPORT OF THE PRODUCT OUTSIDE OF BD FACILITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 12 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES' PLUNGERS WERE DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER DAMAGED".

    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 12 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES' PLUNGERS WERE DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER DAMAGED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254338 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2002277

    Patients

    Seq Age Sex Outcome Treatment
    1