BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 13121252 · Received December 30, 2021

    Report

    Report Number
    1920898-2021-01352
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 3, 2021
    Report Date
    January 7, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED A NUMBER OF IMAGES OF TWO SHELF CARTONS FOR 1ML, 31 GAUGE, 6MM SYRINGES ROM LOT 1102236. ONE SHELF CARTON FEATURES TWO SEPARATE TEARS STARTING AT TWO CORNERS. ANOTHER SHELF CARTON IS MISSING ITS PRINTED LOT NUMBER, MANUFACTURING DATE, AND EXPIRATION DATE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1102236. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE IMAGE RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF LABEL INFORMATION MISSING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    INITIAL REPORTED ADDR 1: (B)(6). 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 · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE INSULIN SYRINGE EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO LOT ON 1 CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE INSULIN SYRINGE EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO LOT ON 1 CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017871 BD ULTRA-FINE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1102236

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown