BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE PLUS X100L PNG CLEAR

    MDR report key: 11356902 · Received February 21, 2021

    Report

    Report Number
    3001741852-2021-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2021
    Date of Event
    January 22, 2021
    Report Date
    January 28, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    MEG
    PMA / PMN Number
    K123743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 #: 6221264, MEDICAL DEVICE EXPIRATION DATE: 2020-07-31, DEVICE MANUFACTURE DATE: 2016-08-08. MEDICAL DEVICE LOT #: 8018996, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2018-01-18. (B)(4). INVESTIGATION SUMMARY: UNCONFIRMED: BD COULD NOT CONFIRM THE REPORTED CONDITION INVESTIGATION CONCLUSION: AS NO SAMPLES WERE PROVIDED, ANALYSIS IS BASED ON THE CUSTOMER PHOTO. VISUAL ANALYSIS APPEARS THAT ALL MOULDED COMPONENTS AND SPRINGS ARE COMPLETE, UNDAMAGED, AND CORRECTLY ASSEMBLED. DEVICE SPRING HAS NOT BEEN ACTIVATED BUT WITHOUT FURTHER ANALYSIS OF THE SAMPLE THIS OBSERVATION CANNOT BE LINKED TO THE PROBLEM SYMPTOM. THEREFORE, THE CONCLUSION OF THE INVESTIGATION INTO PRODUCT MOULDED AND ASSEMBLED AT BD (B)(4) IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 ULTRASAFE PLUS X100L PNG CLEAR EXPERIENCED SEPARATED/BROKEN SAFETY DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE FELL OUT IN THE PLUNGER DIRECTION. THE SYRINGE FELL OUT AFTER ATTACHING THE PLUNGER FOR ONE OF THE 8 MG PRODUCTS, THE OTHER TWO FELL OUT BEFOREHAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253713 ULTRASAFE PLUS X100L PNG CLEAR PISTON SYRINGE MEG BECTON DICKINSON 8018996

    Patients

    Seq Age Sex Outcome Treatment
    1