BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CULTURESWAB¿ PLUS AMIES GEL WITH CHARCOAL, SINGLE SWAB

    MDR report key: 17741389 · Received September 13, 2023

    Report

    Report Number
    1119779-2023-00989
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 31, 2023
    Report Date
    October 9, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSL
    PMA / PMN Number
    K972449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H3. INVESTIGATION SUMMARY: COMPLAINT HISTORY REVIEW: A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS DOES NOT INDICATE A TREND ON THIS ISSUE. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. SAMPLE ANALYSIS: NO PHOTOS OR RETURNS WERE AVAILABLE. THE RETENTION SAMPLES COULD NOT BE INSPECTED AS A LOT NUMBER WAS NOT PROVIDED. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, NO DEFECT WAS OBSERVED. THERE IS NO CONFIRMED TREND ON THIS ISSUE AS A DEFECT. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED. HOWEVER, BD WILL CONTINUE TO MONITOR FOR TRENDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ CULTURESWAB¿ PLUS AMIES GEL WITH CHARCOAL, SINGLE SWAB THERE WAS NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE¿S EXPIRY DATE INQUIRY, AS THE EXPIRY DATE HAS FADED OUT. (B)(4) EXPIRY DATE INQUIRY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ CULTURESWAB¿ PLUS AMIES GEL WITH CHARCOAL, SINGLE SWAB THERE WAS NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE¿S EXPIRY DATE INQUIRY, AS THE EXPIRY DATE HAS FADED OUT. 220121 EXPIRY DATE INQUIRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221319 BD BBL¿ CULTURESWAB¿ PLUS AMIES GEL WITH CHARCOAL, SINGLE SWAB CULTURE MEDIA, ANAEROBIC TRANSPORT JSL BECTON DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown