BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ SHORT NEEDLE INSULIN SYRINGES

    MDR report key: 14855853 · Received June 29, 2022

    Report

    Report Number
    1920898-2022-00420
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 1, 2022
    Report Date
    July 22, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL? YES. D9: RETURNED TO MANUFACTURER ON: 30-JUN-2022. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED A TOTAL OF (7) 1ML, 29 GAUGE, 12.7MM SYRINGE BLISTER PACKS FROM LOT 1173030. ONE OF THE BLISTER PACKS IS MISSING THE PRINT FOR ITS LOT AND MANUFACTURING INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1173030. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF LABEL INFORMATION MISSING. NO ROOT CAUSE PERTAINING TO THIS DEFECT COULD BE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ SHORT NEEDLE INSULIN SYRINGES ONE SYRINGE WAS FOUND TO BE MISSING LOT NUMBER AND DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 X NO LOT NUMBER AND NO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ SHORT NEEDLE INSULIN SYRINGES ONE SYRINGE WAS FOUND TO BE MISSING LOT NUMBER AND DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 X NO LOT NUMBER AND NO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956956 BD ULTRA-FINE¿ SHORT NEEDLE INSULIN SYRINGES HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 1173030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown