BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8518927 · Received April 16, 2019

    Report

    Report Number
    1920898-2019-00355
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    April 1, 2019
    Report Date
    May 21, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (11) LOOSE 0.5ML BD INSULIN SYRINGES. CONSUMER REPORTED SHE FOUND ONE BAG OF SYRINGES WHERE NEEDLES WERE SMALLER THAN THE OTHER SYRINGES IN ONE BOX. ALL 11 RETURNED SAMPLES WERE EXAMINED AND THE CANNULAS OF EACH SYRINGE WERE MEASURED: 2 SYRINGES WERE MEASURED WITH 30G X 12.7MM CANNULAS. IT WAS OBSERVED THAT 1 OF THESE SYRINGES EXHIBITED A CRUSHED BARREL, AND THE OTHER EXHIBITED A BROKEN PLUNGER ROD. 9 SYRINGES WERE MEASURED WITH 31G X 8MM CANNULAS; NO DEFECTS OBSERVED DUE TO THE SAMPLES BEING RECEIVED LOOSE (NOT IN SEALED PACKAGING) THE LOT NUMBERS FOR THE SYRINGES COULD NOT BE CONFIRMED, THEREFORE THE ALLEGED ISSUE OF MIXED PRODUCT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8071803. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200743289] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT (MIXED PRODUCT). THERE WERE TWO (2) NOTIFICATIONS [200747572, 200745873] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT (BARREL DAMAGED, BROKEN PLUNGER). THERE WAS ONE (1) NOTIFICATION [200747574] NOTED FOR DAMAGED BARRELS. THERE WAS ONE (1) NOTIFICATION [200743289] NOTED FOR DAMAGED CORES. THERE WAS ONE (1) NOTIFICATION [200746005] NOTED FOR BROKEN FLANGE. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (MIXED PRODUCT). CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES (CRUSHED BARREL & BROKEN PLUNGER ROD). POSSIBLE ROOT CAUSES FOR CRUSHED BARREL: DEFECT COULD HAVE OCCURRED AT THE PREP DIAL OF THE METRO ASSEMBLY MACHINE LOSS OF BACK PRESSURE ON THE IN-FEED RAIL MAY CAUSE THE BARREL TO BECOME PINCHED AT THE RAIL / PREP DIAL JUNCTION. THE TRIP GATE EYE SENSOR SHOULD DETECT LOW RAIL CONDITIONS AND ACTIVATE THE TRIP GATE TO PREVENT THE BARRELS FROM BEING LOADED INTO THE PREP DIAL AND POSSIBLY JAMMING AT THAT LOCATION. INFEED DIAL AT BARREL PRINTERS. LOSS OF BACK PRESSURE AT INFEED RAIL ALSO AT FORM FILL & SEAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BAG OF "SMALLER" SYRINGE NEEDLES WERE FOUND IN THE BOX OF BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED SHE FOUND ONE BAG OF SYRINGES WHERE NEEDLES WERE SMALLER THAN THE OTHER SYRINGES IN ONE BOX.".

    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 A BAG OF "SMALLER" SYRINGE NEEDLES WERE FOUND IN THE BOX OF BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED SHE FOUND ONE BAG OF SYRINGES WHERE NEEDLES WERE SMALLER THAN THE OTHER SYRINGES IN ONE BOX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313889 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8071803 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other