BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL EURO 125 S/C

    MDR report key: 8775294 · Received July 10, 2019

    Report

    Report Number
    1213809-2019-00721
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 24, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: FIVE PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED A 5ML SYRINGE IN A FULLY SEALED BLISTER PACK. ONE PHOTO SHOWED A LOOSE 5ML SYRINGE WITH FADED GRAD LINES BETWEEN THE 2ML AND 5ML MARKINGS. ONE PHOTO SHOWED A BLANK BARREL NEXT TO A PHOTO WITH WHAT APPEARS TO BE INK RESIDUE ON A FINGER. ONE PHOTO DISPLAYED A LOOSE 5ML SYRINGE WITH NO VISUAL DEFECTS. IT IS UNCLEAR HOW THE SYRINGE WAS HANDLED PRIOR TO THE INK BEING REMOVED AND WHAT TYPE OF RUB TEST WAS PERFORMED. PHYSICAL SAMPLES ARE NEEDED TO PERFORM INK PERMANENCY TESTS. THE SYRINGES ARE INTENDED FOR SINGLE USE ONLY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. BASED ON THE EVIDENCE PROVIDED THE SCALE PERMANENCY DEFECT COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 5ML LL EURO 125 S/C EXPERIENCED SCALE MARKING ISSUES/SCALE MARKING PERMANENCY ISSUES NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON A SAMPLE TEST TO FIT THE SYRINGE TO THE TUBE, THE PRINT OF THE LOGO APPEARED TO COME OFF. ONE FURTHER RUB TEST CLEARED ALL PRINT FROM SYRINGE. THE PRODUCT CODE IS BD309649. LOT NUMBER 9070842. LOT NUMBER 9092690.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9070842, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-03-11. MEDICAL DEVICE LOT #: 9092690, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-04-02. DEVICE EVALUATED BY MFR: 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 AN UNSPECIFIED NUMBER OF SYRINGE 5ML LL EURO 125 S/C EXPERIENCED SCALE MARKING ISSUES/SCALE MARKING PERMANENCY ISSUES NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON A SAMPLE TEST TO FIT THE SYRINGE TO THE TUBE, THE PRINT OF THE LOGO APPEARED TO COME OFF. ONE FURTHER RUB TEST CLEARED ALL PRINT FROM SYRINGE. THE PRODUCT CODE IS BD309649. LOT NUMBER 9070842, LOT NUMBER 9092690.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569792 SYRINGE 5ML LL EURO 125 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other