BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET CONTROL COR HPV

    MDR report key: 16850174 · Received May 1, 2023

    Report

    Report Number
    1119779-2023-00511
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Date of Event
    April 3, 2023
    Report Date
    May 7, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MAQ
    PMA / PMN Number
    P160037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.6 INITIAL REPORTER E-MAIL: (B)(6). G5. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE CONTROL SET FOR THE BD ONCLARITY¿ HPV ASSAY, CATALOG NUMBER 444088 WITH 510K #P160037. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD INTEGRATED DIAGNOSTIC SYSTEMS INITIATED AN INVESTIGATION REGARDING A MISSING BARCODE ON A HPV NEGATIVES CONTROL (CATALOG # 441993, BATCH # 2311167) ON THE BD VIPER LT SYSTEM. BD INVESTIGATION REQUIRED A REVIEW OF THE BATCH HISTORY RECORDS, REVIEW OF CUSTOMER RETURNED PHOTOGRAPHIC EVIDENCE, REVIEW OF RETENTION MATERIAL FROM THE CUSTOMERS REPORTED REAGENT BATCH AND COMPLAINT TRENDING REVIEW. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. REVIEW OF RETENTION MATERIAL FROM THE CUSTOMERS REPORTED REAGENT BATCH REVEALED PROPERLY LABELED HPV NEGATIVE CONTROLS. HOWEVER, REVIEW OF THE RETURNED PHOTOGRAPHIC EVIDENCE REVEALED A MISSING BARCODE ON A HPV NEGATIVE CONTROL, THUS CONFIRMING THE CUSTOMERS COMPLAINT. THERE ARE NO CURRENT COMPLAINT TRENDS ASSOCIATED WITH A MISSING BARCODE ON A HPV NEGATIVE CONTROL. BD WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. NO CORRECTIVE ACTIONS WERE TAKEN AT THIS TIME. BD APOLOGIZES FOR ANY INCONVENIENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE SET CONTROL COR HPV THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO LOT# ON ONE OF THE TUBES ON ONE OF THE TUBES (NEG CONTROL) THERE WAS NO LOT# PRINTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE SET CONTROL COR HPV THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO LOT # ON ONE OF THE TUBES ON ONE OF THE TUBES (NEG CONTROL) THERE WAS NO LOT # PRINTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247657 SET CONTROL COR HPV NA MAQ BECTON, DICKINSON & CO. (SPARKS) 2311167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown