BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE

    MDR report key: 10782748 · Received November 3, 2020

    Report

    Report Number
    1920898-2020-01529
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 13, 2020
    Report Date
    December 3, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 11/18/2020. H.6. INVESTIGATION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR PLUNGER ROD DIFFICULT TO MOVE ON LOT # 0013076. CUSTOMER RETURNED (15) LOOSE 31GX6MM, 0.5ML BD INSULIN SYRINGES. CONSUMER REPORTED THAT THE PLUNGER WAS HARD TO MOVE. ALL 15 RETURNED SYRINGES WERE EXAMINED, THEN TESTED FOR PLUNGER ROD MOVEMENT: EACH PLUNGER ROD WAS EXERCISED WITHIN ITS RESPECTIVE BARREL, AND IT WAS OBSERVED THAT ALL 15 PLUNGER RODS WERE ABLE TO MOVE PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED, THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0013076. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE WAS UNABLE/DIFFICULT TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:324911 BATCH NO: 0013076. CONSUMER REPORTED FINDING PLUNGER HARD TO MOVE DURING DRAWING UP N BUT NOT R WHEN MIXING. CONSUMER NOT PLACING AIR INTO VIAL OF N BEFORE DRAWING UP INSULIN. ADVISED TO PLACE PROPER AMOUNTS OF AIR VS INSULIN INTO EACH VIAL WITHOUT DATE OF EVENT UNKNOWN AND FOR THE PAST YEAR MOST ALL.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE WAS UNABLE/DIFFICULT TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:324911 BATCH NO: 0013076. CONSUMER REPORTED FINDING PLUNGER HARD TO MOVE DURING DRAWING UP N BUT NOT R WHEN MIXING. CONSUMER NOT PLACING AIR INTO VIAL OF N BEFORE DRAWING UP INSULIN. ADVISED TO PLACE PROPER AMOUNTS OF AIR VS INSULIN INTO EACH VIAL WITHOUT DATE OF EVENT UNKNOWN AND FOR THE PAST YEAR MOST ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241415 BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324911 0013076 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1