BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE

    MDR report key: 12713864 · Received October 28, 2021

    Report

    Report Number
    1920898-2021-01117
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    September 30, 2021
    Report Date
    November 12, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-10-26. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A TOTAL OF 39 0.3ML SYRINGES. NO OTHER IDENTIFICATION WAS PROVIDED. EACH SYRINGE WAS INSPECTED TO ENSURE THAT IT WAS WITHIN SPECIFICATIONS. FOUR OF THE RETURNED SYRINGES REQUIRED FURTHER VOLUMETRIC MEASUREMENTS, AS THE ALIGNMENT OF THEIR GRADUATION MARKINGS COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1102431. 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 SAMPLES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE GRADUATION MARKINGS NOT BEING IN ALIGNMENT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS : LOT # : 1102431 ¿ DEVICE EXPIRATION DATE : 04/30/2026. ¿ DEVICE MANUFACTURE DATE : 04/12/2021. LOT # : UNKNOWN ¿ DEVICE EXPIRATION DATE : UNKNOWN. ¿ DEVICE MANUFACTURE DATE : UNKNOWN. 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 2 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLES HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED FINDING ABOUT HALF THE SYRINGES FROM CURRENT BOX AND IN 3 PRIOR BOXES THE SCALE MARKINGS DO NOT START AT THE 0 MARKER. DATE OF EVENT : UNKNOWN . SAMPLE STATUS : CURRENT BOX - AWAITING SAMPLE; PREVIOUS BOXES - DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLES HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED FINDING ABOUT HALF THE SYRINGES FROM CURRENT BOX AND IN 3 PRIOR BOXES THE SCALE MARKINGS DO NOT START AT THE 0 MARKER. DATE OF EVENT : UNKNOWN. SAMPLE STATUS : CURRENT BOX - AWAITING SAMPLE. PREVIOUS BOXES - DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610567 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown