BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT TROUGH PCR EXTRACTION

    MDR report key: 13653999 · Received March 2, 2022

    Report

    Report Number
    1119779-2022-00336
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    February 2, 2022
    Report Date
    March 17, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MAQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD INTEGRATED DIAGNOSTIC SYSTEMS INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING ONE (1) VIPER LT REAGENT TROUGH WITH A TORN ABSORBENT PAD AND ONE (1) VIPER LT REAGENT TROUGH WITH A MISSING BARCODE LABEL WHILE USING BATCH NUMBERS 1152984 AND 1165772, RESPECTIVELY. BD INVESTIGATION REQUIRED REVIEW OF THE BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION MATERIALS AND RETURNED PHOTOGRAPHIC EVIDENCE AS WELL AS COMPLAINT TRENDING REVIEW. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. VISUAL INSPECTION OF RETENTION MATERIALS REVEALS IN-TACT ABSORBENT PADS AND BARCODE LABEL PRESENCE. HOWEVER, REVIEW OF THE CUSTOMERS SUBMITTED PHOTOGRAPHIC EVIDENCE REVEALS ONE (1) VIPER LT REAGENT TROUGH WITH A TORN ABSORBENT PAD AND ONE (1) VIPER LT REAGENT TROUGH WITH A MISSING BARCODE LABEL, THUS CONFIRMING THE CUSTOMERS REPORT. THERE IS NO CURRENT TRENDS OVER THE PAST YEAR AGAINST VIPER LT REAGENT TROUGH WITH A MISSING BARCODE LABELS. HOWEVER, THERE IS A TREND AGAINST VIPER LT REAGENT TROUGHS WITH TORN ABSORBENT PADS (4 COMPLAINTS AND 4 TOTAL CONFIRMED TROUGHS OVER THE PAST YEAR). BASED ON THIS TREND, A CORRECTIVE AND PREVENTIVE ACTION INITIATION DETERMINATION WAS COMPLETED AND IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME ((B)(4)). THE SUBMITTED RETURNED PHOTOGRAPHIC EVIDENCE WAS FORWARD TO MANUFACTURING MANAGEMENT FOR AWARENESS AND REVIEW WITH RESPONSIBLE ASSOCIATES. BD WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH VIPER LT REAGENT TROUGHS WITH TORN ABSORBENT PADS AND/OR MISSING BARCODE LABEL. THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. 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 · 0

    IT WAS REPORTED THAT REAGENT TROUGH PCR EXTRACTION WAS RECEIVED BY THE CUSTOMER WITH A LABEL MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE BARCODE WAS MISSING (LOT#1165772).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REAGENT TROUGH PCR EXTRACTION WAS RECEIVED BY THE CUSTOMER WITH A LABEL MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE BARCODE WAS MISSING (LOT#1165772).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338009 REAGENT TROUGH PCR EXTRACTION KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ BECTON, DICKINSON & CO. (SPARKS) 1165772

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown