BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ IV INSULIN SYRINGE

    MDR report key: 8126730 · Received December 3, 2018

    Report

    Report Number
    1920898-2018-00907
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 14, 2018
    Report Date
    January 2, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903294207
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. THERE WAS ONE (1) BATCH OF MATERIAL# 8365002 (SYRINGE 1.0ML ASM BLS 28G 1/2IN SM700167) THAT WENT INTO FINISHED BATCH# 7240669. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7121840. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE THERE WAS AN ISSUE WITH NEEDLES BREAKING DURING INJECTION OR WHEN RECAPPING.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7240669, MEDICAL DEVICE EXPIRATION DATE: 2022-10-31, DEVICE MANUFACTURE DATE: 2017-08-28. MEDICAL DEVICE LOT #: 7121840, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2017-05-01. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (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 · 1

    IT WAS REPORTED WITH THE USE OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE THERE WAS AN ISSUE WITH NEEDLES BREAKING DURING INJECTION OR WHEN RECAPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965048 BD MICRO-FINE¿ IV INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10 30382903294207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other