BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT TROUGH PCR EXTRACTION

    MDR report key: 12178040 · Received July 15, 2021

    Report

    Report Number
    1119779-2021-01178
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 17, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MAQ
    PMA / PMN Number
    P160037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD MOLECULAR QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING UNKNOWN MATTER ON THE TOP FOIL OF ONE (1) VIPER LT LINEAR TROUGH. QUALITY INVESTIGATION REQUIRED REVIEW OF THE BATCH HISTORY RECORDS AS WELL AS VISUAL INSPECTION OF RETENTION MATERIALS AND RETURNED PHOTOGRAPHIC EVIDENCE, REVIEW OF CONFIRMATION EVIDENCE WITH BD OPERATIONS AS WELL AS COMPLAINT TRENDING REVIEW. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. MANUAL INSPECTION OF RETENTION MATERIALS DOES NOT REVEAL ABNORMAL MATTER PRESENCE. HOWEVER, REVIEW OF RETURNED PHOTOGRAPHIC EVIDENCE DOES REVEAL UNKNOWN MATTER ON THE TOP FOIL OF (1) VIPER LT LINEAR TROUGH, THUS CONFIRMING THE CUSTOMERS REPORT. REVIEW OF CONFIRMATION EVIDENCE WITH BD OPERATIONS REVEALS THE ROOT CAUSE TO BE REMNANTS OF A WORN SOLDIER IRON. USE OF THE CONFIRMED REAGENT THROUGH CAN BE USED AND SHOULD NOT AFFECT ASSAY PERFORMANCE. COMPLAINT TRENDING REVIEW REVEALS THIS TO BE THE FIRST REPORT OF THIS NATURE OVER THE PAST YEAR, WHICH BD IS CONSIDERING TO BE AN ISOLATED INCIDENT AT THIS TIME. BD MOLECULAR QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH UNKNOWN MATTER ON THE TOP FOIL OF (1) VIPER LT LINEAR TROUGH. THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD VIPER¿ PCR EXTRACTION REAGENT TROUGH WITH PIERCING TOOL CATALOG NUMBER 444087 WHICH HAS 510K NUMBER P160037.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING REAGENT TROUGH PCR EXTRACTION FUNGAL CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " REAGENT TROUGH HAS FUNGUS ON TOP OF TRAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068350 REAGENT TROUGH PCR EXTRACTION KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ BECTON, DICKINSON & CO. (SPARKS) 1040724

    Patients

    Seq Age Sex Outcome Treatment
    1