BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7915692 · Received September 27, 2018

    Report

    Report Number
    1920898-2018-00750
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    August 20, 2018
    Report Date
    October 25, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 3/10CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG WITH PART OF THE SHELF CARTON FROM LOT # 7352721. CUSTOMER STATES THAT SCALE PRINT IS MISSING. THE RETUNED SYRINGE WAS EXAMINED AND EXHIBITED PART OF THE SCALE MARKINGS TO BE MISSING. CAPA 162566 WAS INITIATED TO ADDRESS SUCH ISSUES AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7352721. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200735897] NOTED FOR SCRATCHED PRINT. THERE WAS ONE (1) NOTIFICATION [200735784] NOTED FOR BLANK BARRELS. THERE WERE THREE (3) NOTIFICATIONS [200736062, 200736216, 200735882] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. POSSIBLE ROOT CAUSES FOR MISSING SCALE MARKINGS INCLUDE: DAMAGE TO THE PAD. PRINT DRUM NOT TOUCHING THE PAD FOR INK TRANSFER. PAD HEAT SET INCORRECTLY. PRINT HEAD TIMING OUT OF ADJUSTMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE WAS MISSING THE SCALE MARKINGS ON THE BARREL. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    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 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE WAS MISSING THE SCALE MARKINGS ON THE BARREL. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755482 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7352721 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other