BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SWAB BBL SGL F/F

    MDR report key: 12502877 · Received September 20, 2021

    Report

    Report Number
    1119779-2021-01547
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    August 24, 2021
    Report Date
    December 2, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTX
    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

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 1119779-2021-01547 WAS SENT IN ERROR. ACCORDING TO PICTURE RECEIVED FROM CUSTOMER, THE LABEL IS NOT MISSING THE INSERT WAS DETACHED, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 50 BD SWAB BBL SGL F/F EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE DOCUMENT WHICH WAS SUPPOSED TO BE AFFIXED TO THE PACKAGE WAS DETACHED AND FOUND SEPARATELY.

    Additional Manufacturer Narrative · 1

    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 THAT 50 BD SWAB BBL SGL F/F EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE DOCUMENT WHICH WAS SUPPOSED TO BE AFFIXED TO THE PACKAGE WAS DETACHED AND FOUND SEPARATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400032 BD SWAB BBL SGL F/F SYSTEM, TRANSPORT, ANAEROBIC JTX BECTON, DICKINSON & CO. (SPARKS) 203203800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown