BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT GRP A STREP 30 TEST VERITOR

    MDR report key: 12845343 · Received November 19, 2021

    Report

    Report Number
    1119779-2021-01859
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 28, 2021
    Report Date
    January 24, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    GTY
    UDI-DI
    00382902560401
    PMA / PMN Number
    K122718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES WHEN USING KIT GRP A STREP 30 TEST VERITOR (MATERIAL # 256040), BATCH NUMBER 6982, THE SWAB TIP FELL IN THE CUSTOMER MOUTH. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE BATCH NUMBER PROVIDED WAS FOR THE SWAB AND NOT THE KIT. THE NOTED SWAB BATCH NUMBER WENT INTO 20 DIFFERENT KIT GRP A STREP 30 TEST VERITOR (MATERIAL # 256040) BATCH NUMBERS. UNABLE TO DETERMINE WHICH BATCH WAS ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A TREND ANALYSIS FOR SAFETY (BROKEN SWAB) WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT NUMBER: LOT # 6982 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE KIT GRP A STREP 30 TEST VERITOR, THE SWAB TIP FELL OFF INTO THE PATIENT'S MOUTH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER SAYS THE SWAB TIP IS FALLING OFF IN PATIENTS MOUTH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE KIT GRP A STREP 30 TEST VERITOR, THE SWAB TIP FELL OFF INTO THE PATIENT'S MOUTH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER SAYS THE SWAB TIP IS FALLING OFF IN PATIENTS MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742253 KIT GRP A STREP 30 TEST VERITOR ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY BECTON, DICKINSON & CO. (SPARKS) 256040 6982 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown