BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 11529402 · Received March 19, 2021

    Report

    Report Number
    1213809-2021-00148
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 22, 2021
    Report Date
    March 29, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO OF A LOOSE 10ML SYRINGE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS SMALL AREAS OF MISSING PRINT NEAR THE 9ML MARKING. THE MISSING PRINT HAD A DRAGGED OR SCRAPED APPEARANCE. NO SINGLE ITEM WAS MISSING MORE THAN 50% WHICH WAS ACCEPTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT MAY BE ASSOCIATED WITH THE ASSEMBLY PROCESS. IT IS POSSIBLE THERE WAS A SLIGHT MISFEED CAUSING THE PRINT TO BE RUBBED OFF. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL BNS HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 30102, BATCH NO: 9190569. IT WAS REPORTED SYRINGE WITH BLURRED LETTERS.

    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 SYRINGE 10ML LL BNS HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301029, BATCH NO: 9190569. IT WAS REPORTED SYRINGE WITH BLURRED LETTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428882 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9190569

    Patients

    Seq Age Sex Outcome Treatment
    1