BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL SP125

    MDR report key: 8683808 · Received June 10, 2019

    Report

    Report Number
    1213809-2019-00606
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 24, 2019
    Report Date
    July 8, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO AND 28 PHYSICAL SAMPLES CONFIRMED TO BE FROM BATCH #9060905 (P/N 309646) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED 27 OF THE SAMPLES WERE FULLY SEALED BLISTER PACKS CONTAINING SYRINGES WITH NO VISIBLE PRINT. ONE OF THE SAMPLES WAS A FULLY SEALED BLISTER PACK WITH NOTHING INSIDE. ALL 28 SAMPLES WERE REJECTABLE PER PRODUCT SPECIFICATION. FURTHERMORE, 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. MACHINE LOGS INDICATE MARKER ISSUES DURING PRODUCTION OF THIS BATCH. MARKER ADJUSTMENTS WERE RECORDED TO CORRECT ISSUES. POTENTIAL ROOT CAUSE FOR BLANK BARRELS IS LIKELY ASSOCIATED WITH MARKER ADJUSTMENTS DUE TO ISSUES FOUND DURING THE MARKING PROCESS. CORRECTIONS TOOK PLACE AT THE TIME ISSUES WERE DISCOVERED DURING THE MANUFACTURE OF THIS BATCH. IT IS POSSIBLE THAT DURING ADJUSTMENTS INCOMPLETE CONTAINMENT OF BLANK BARRELS ALLOWED A LIMITED NUMBER TO GET MIXED IN WITH THE GOOD PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 28 SYRINGE 5ML LL SP125 EXPERIENCED MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309646 BATCH NO.: 9060905 VERBATIM: 5ML SYRINGE WITH NO UNIT MARKINGS ON THE SYRINGES.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 28 SYRINGE 5ML LL SP125 EXPERIENCED MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309646, BATCH NO.: 9060905. VERBATIM: 5ML SYRINGE WITH NO UNIT MARKINGS ON THE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477379 SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9060905 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other