BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 31G 6MM 30BOX MEX

    MDR report key: 15686478 · Received October 27, 2022

    Report

    Report Number
    9614033-2022-00092
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 4, 2022
    Report Date
    November 17, 2022
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED SEVERAL PHOTOS OF A 0.3ML, 31 GUAGE, 6MM SYRINGE FROM LOT # 2111096. THE CUSTOMER REPORTED THAT WHEN THE ORANGE CAP WAS REMOVED THE SYRINGE CAME OUT WITH EVERYTHING AND A NEEDLE. THE PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL, THE CANNULA HUB WAS NO LONGER ATTACHED TO THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2111096. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN REMOVING THE CAP OF THE BD ULTRA-FINE 6MM¿ INSULIN SYRINGE THE NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: I REGULARLY BUY YOUR INSULIN SYRINGES FOR MY TREATMENT, HOWEVER IT HAPPENED TO ME THAT WHEN I REMOVED THE ORANGE CAP A SYRINGE CAME OUT WITH EVERYTHING AND A NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN REMOVING THE CAP OF THE BD ULTRA-FINE 6MM¿ INSULIN SYRINGE THE NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: I REGULARLY BUY YOUR INSULIN SYRINGES FOR MY TREATMENT, HOWEVER IT HAPPENED TO ME THAT WHEN I REMOVED THE ORANGE CAP A SYRINGE CAME OUT WITH EVERYTHING AND A NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2912638 BD SYRINGE 0.3ML 31G 6MM 30BOX MEX PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 2111096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown