BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II SHORT-NEEDLE INSULIN SYRINGE

    MDR report key: 13970236 · Received March 31, 2022

    Report

    Report Number
    1920898-2022-00203
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 18, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED SEVERAL IMAGES OF A SHELF CARTON AND POLYBAGS FOR 0.3ML, 30 GAUGE, 8ML SYRINGES FROM LOT 1102409. ONE OF THE POLYBAGS APPEARS TO BE MISSING THE LOT AND MANUFACTURING INFORMATION PRINTED ON THE REVERSE SIDE. ANOTHER APPEARS TO HAVE AN OPEN SEAL ON THIS SIDE AS WELL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1102409 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE IMAGES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF LABEL INFORMATION MISSING.

    Description of Event or Problem · 0

    IT WAS REPORTED BD ULTRA-FINE¿ II SHORT-NEEDLE INSULIN SYRINGE WAS MISSING LOT INFORMATION ON ITS SHELF CARTON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...NO VENDOR LOT."

    Description of Event or Problem · 0

    IT WAS REPORTED BD ULTRA-FINE¿ II SHORT-NEEDLE INSULIN SYRINGE WAS MISSING LOT INFORMATION ON ITS SHELF CARTON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...NO VENDOR LOT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782852 BD ULTRA-FINE¿ II SHORT-NEEDLE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1102409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown