BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 14706060 · Received June 15, 2022

    Report

    Report Number
    1911916-2022-00297
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 16, 2022
    Report Date
    May 26, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS A SCALE MARKING ISSUE. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A PACKAGING BLISTER WITH A SYRINGE THAT HAS SKEWED SCALE PRINTING. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303552, LOT NUMBER 1103472. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE SYRINGE BARREL PRINTING PROCESS WAS PERFORMED. THE SETTINGS AND ALIGNMENT WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAS BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGES EXPERIENCED SCALE PRINTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS IDENTIFIED THE SCALE PRINTING IS NOT STRAIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132223 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1103472

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown