BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 11402857 · Received March 3, 2021

    Report

    Report Number
    1920898-2021-00250
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 4, 2021
    Report Date
    February 18, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903201228
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE BENT ON LOT # 0062051. INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) 3/10CC, 12.7MM, 29G SYRINGES IN AN OPEN POLY BAG FROM LOT # 0062051. CUSTOMER STATES THAT THE NEEDLE WAS BENT. ALL RETURNED SYRINGES WERE EXAMINED AND ONE EXHIBITED A SLIGHTLY BENT CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0062051 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE IS USER RELATED. THE CANNULA BENT DURING USE OF THE PRODUCT BY THE CUSTOMER. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP HAD SCALE MARKING ISSUES DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED ABOUT FIVE SYRINGES FOR WHICH THE SCALE WAS MISALIGNED. (B)(4) 2021/2/18. A CUSTOMER'S MEMO SAID THAT 2 ISSUES HAVE OCCURRED. THE SCALE WAS MISALIGNED. THE NEEDLE WAS BENT. BDJ ADDED ROW#2 FOR " NEEDLE BENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303054 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 320122 0062051 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1