BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET CONTROL COR HPV

    MDR report key: 16873202 · Received May 4, 2023

    Report

    Report Number
    1119779-2023-00527
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Date of Event
    April 5, 2023
    Report Date
    May 31, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MAQ
    PMA / PMN Number
    P160037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.4 INITIAL REPORTER PHONE #: (B)(6). E.6 INITIAL REPORTER E-MAIL: (B)(6). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. 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

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: BD INTEGRATED DIAGNOSTIC SYSTEMS INITIATED AN INVESTIGATION INTO MISSING BARCODES ON THE HPV NEGATIVE CONTROL FOR THE BD VIPER LT AND BD COR SYSTEMS (CATALOG # 445026, BATCH # 2257436). BD INVESTIGATION REQUIRED REVIEW OF THE BATCH HISTORY RECORDS, REVIEW OF MATERIALS FROM THE CUSTOMERS REPORTED REAGENT BATCH, REVIEW OF CUSTOMER RETURNED PHOTOGRAPHIC EVIDENCE AND COMPLAINT TRENDING REVIEW. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF RETENTION MATERIALS FROM THE CUSTOMERS REPORTED REAGENT BATCH DID NOT REVEAL ANY MISSING BARCODE INFORMATION ON HPV NEGATIVE CONTROLS. HOWEVER, REVIEW OF THE CUSTOMERS RETURNED PHOTOGRAPHIC EVIDENCE REVEALED MISSING BARCODE INFORMATION ON HPV NEGATIVE CONTROLS, THUS CONFIRMING THE CUSTOMERS COMPLAINT. THERE IS CONFIRMED COMPLAINT TREND FOR MISSING BARCODES ON THE HPV NEGATIVE CONTROL FOR THE BD VIPER LT AND BD COR SYSTEMS FOR THE MONTH OF APRIL, HOWEVER NO CORRECTIVE ACTIONS ARE BEING TAKEN AT THIS TIME. BD APOLOGIZES FOR ANY INCONVENIENCE. IF THERE ARE ANY QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE SET CONTROL COR HPV THAT THERE WAS A MISSING LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THE NEGATIVE CONTROL HAD NO BARCODE AND COULD NOT BE READ BY COR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE SET CONTROL COR HPV THAT THERE WAS A MISSING LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THE NEGATIVE CONTROL HAD NO BARCODE AND COULD NOT BE READ BY COR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620963 SET CONTROL COR HPV NA MAQ BECTON, DICKINSON & CO. (SPARKS) 2257436

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown