BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2"

    MDR report key: 17495317 · Received August 9, 2023

    Report

    Report Number
    1920898-2023-00549
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 25, 2023
    Report Date
    October 19, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903266319
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 2234021. D4: MEDICAL DEVICE EXPIRATION DATE: 22-AUG-2023. H4: DEVICE MANUFACTURE DATE: 30-SEP-2027. D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 29-AUG-2023 . H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (1) 0.3ML 29G 12.7MM SYRINGE IN AN OPEN POLYBAG FROM THE LOT# 2234021. THE CUSTOMER REPORTED THAT THE NEEDLE HUB CAME OFF. THE NEEDLE HUB CAME OFF TOGETHER WITH THE CAP WHEN CHECKING BEFORE USE. THE RETURNED SAMPLE VISUALLY EXAMINED AND OBSERVED NO ISSUES WITH NEEDLE HUB SEPARATES. NO ISSUES WERE OBSERVED WITH NEEDLE HUB DURING SHIELD ATTACHMENT/DETACHMENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2234021. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. UNCONFIRMED: BASED ON THE RETURN SAMPLES, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE. ROOT CAUSE CANNOT BE DETERMINED AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2" THE HUB SEPARATED FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT THE NEEDLE HUB CAME OFF. THE NEEDLE HUB CAME OFF TOGETHER WITH THE CAP WHEN CHECKING BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2" THE HUB SEPARATED FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT THE NEEDLE HUB CAME OFF. THE NEEDLE HUB CAME OFF TOGETHER WITH THE CAP WHEN CHECKING BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543277 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2" PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2234021 00382903266319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown