BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 8679407 · Received June 7, 2019

    Report

    Report Number
    1920898-2019-00520
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 28, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (3) 3/10CC, 6MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 8043556. CUSTOMER STATES THAT THE SYRINGE WILL NOT DRAW, THE PLUNGER ROD GOES BACK TO THE TOP WHEN HE TRIES TO DRAW THE INSULIN, AND THERE IS AIR IN THE SYRINGES. ALL RETURNED SYRINGES WERE TESTED AND NO SAMPLE WAS ABLE TO DRAW PROPERLY. THE SAMPLES WERE THEN WIRED AND THE WIRE WAS NOT ABLE TO PASS THOUGH THE CANNULA, INDICATING AN ADHESIVE CLOG IN THE CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8043556. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. POSSIBLE ROOT CAUSE: DURING THE PARTS PASS UNDER THE CORONA TREATER PINS AND EXPOSED TO AN ION RICH CORONA FIELD, WHICH INCREASES SURFACE ENERGY WETTABILITY TO AID IN THE ADHESION OF THE ADHESIVE TO THE HUB. THE PULLOUT DEVICE MOVES THE CANNULA OUT A SMALL DISTANCE FOR ADHESIVE TO BE APPLIED AND PULLED INTO THE HUB WITH VACUUM. OPPORTUNITY TO HAVE MORE FLOW OF ADHESIVE UNDER CANNULA AND CHANCES OF GETTING ADHESIVE CLOG. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    MATERIAL NO. 324909 BATCH NO. 8043556. IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE THE SYRINGES ARE NOT DRAWING INSULIN. ALSO REPORTED THERE IS AIR IN SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT HIS SYRINGE WILL NOT DRAW, STATED THAT THE PLUNGER ROD GOES BACK TO THE TOP WHEN HE TRIES TO DRAW THE INSULIN. ALSO STATED THAT SOMETIMES THERE IS AIR IN THE SYRINGES. DOES NOT RE-USE, PROBLEM WITH CURRENT BOX OCCURRED A FEW DAYS AGO, PROBLEM IS ONGOING. CONSUMER STATED THAT THE ISSUE IS WITH THE SAME BOX AND LOT FROM LOT # 8043556, PRODUCT # 324909, EXP 03-31-2023.

    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 324909, BATCH NO. 8043556. IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE THE SYRINGES ARE NOT DRAWING INSULIN. ALSO REPORTED THERE IS AIR IN SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT HIS SYRINGE WILL NOT DRAW, STATED THAT THE PLUNGER ROD GOES BACK TO THE TOP WHEN HE TRIES TO DRAW THE INSULIN. ALSO STATED THAT SOMETIMES THERE IS AIR IN THE SYRINGES. DOES NOT RE-USE, PROBLEM WITH CURRENT BOX OCCURRED A FEW DAYS AGO, PROBLEM IS ONGOING. CONSUMER STATED THAT THE ISSUE IS WITH THE SAME BOX AND LOT FROM LOT # 8043556, PRODUCT # 324909, EXP 03-31-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472783 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8043556 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other