BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ 8MM X 31G NEEDLE

    MDR report key: 13387385 · Received January 28, 2022

    Report

    Report Number
    1920898-2022-00045
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    January 11, 2022
    Report Date
    February 25, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: CUSTOMER RETURNED (10) 0.3ML BD INSULIN SYRINGES FROM LOT# 1011576. THE CUSTOMER REPORTED THAT THE VERY FIRST SCALE MARK IS LOWER THAN IT SHOULD BE, AND IT IS DIFFICULT TO MEASURE THE EXACT AMOUNT OF DRUG INJECTION. THE RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT 1 SYRINGE WAS MISSING A 0-UNIT SCALE MARKING. THE REMAINING SYRINGES WERE TESTED USING A 0.3ML PLUG GAUGE, AND IT WAS OBSERVED THAT THE LEADING EDGE OF 1 SYRINGE DID NOT FALL WITHIN THE PLUG GAUGE SPEC. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1011576. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED FOR SCRATCHED PRINT. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ 8MM X 31G NEEDLE EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE VERY FIRST SCALE MARK (ZERO POINT) IS LOWER THAN IT SHOULD BE AND IT IS DIFFICULT TO MEASURE THE EXACT AMOUNT OF DRUG INJECTION. EVEN THOUGH THE PRODUCTS ARE IN THE SAME BOX, THE POSITION OF THE SCALE MARKS IS DIFFERENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ 8MM X 31G NEEDLE EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE VERY FIRST SCALE MARK (ZERO POINT) IS LOWER THAN IT SHOULD BE AND IT IS DIFFICULT TO MEASURE THE EXACT AMOUNT OF DRUG INJECTION. EVEN THOUGH THE PRODUCTS ARE IN THE SAME BOX, THE POSITION OF THE SCALE MARKS IS DIFFERENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762816 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ 8MM X 31G NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1011576

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown