BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML VIAL

    MDR report key: 15135695 · Received July 29, 2022

    Report

    Report Number
    1119779-2022-01050
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    July 5, 2022
    Report Date
    December 6, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSM
    UDI-DI
    30382902202203
    PMA / PMN Number
    K042970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H.6 INVESTIGATION SUMMARY: THIS MEMO SERVES TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT 5520009 ON PRODUCT 220220 (VIAL UNIVERSAL VIRAL TRANSPORT), LOT NUMBER N03068100, WHERE IT WAS OBSERVED THAT THERE WAS A DISCREPANCY BETWEEN THE EXPIRATION DATE LISTED ON THE PRODUCT CERTIFICATE/KIT LABEL AND THE TUBE LABEL. EVENT DESCRIPTION: " UVT 220220 LABELING ISSUE." 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 DOES INDICATE A DISCREPANCY BETWEEN THE TUBE LABEL AND THE REST OF THE PRODUCT LABELING. SAMPLE ANALYSIS: THE PHOTOS PROVIDED DID SHOW THE NOTED DEFECT. THE DATE ON THE TUBE DOES NOT MATCH THE DATE ON THE PRODUCT LABELING. THE RETENTION SAMPLES COULD NOT BE INSPECTED AS THE COMPLAINT WAS RECEIVED MONTHS AFTER THE PRODUCT HAD BEEN EXPIRED AND THE RETENTION SAMPLES WERE NO LONGER AVAILABLE. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, THE PHOTOS SHOWED THE NOTED DEFECT. WHILE THERE IS NO SYSTEMIC FAILURE IN THE MANUFACTURING PROCESS, A REVISION TO THE MANUFACTURING SOP HAS BEEN COMPLETED TO INCREASE CONTROLS AROUND THE ASSIGNMENT OF EXPIRATION DATE AND REDUCE THE POSSIBILITY FOR DATA ENTRY ERRORS. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS CONFIRMED ON THE PHOTOS. OTHER THAN THE REVISION TO THE SOP, NO FURTHER ACTIONS WILL BE TAKEN AS CONFIRMED TREND HAS NOT BEEN IDENTIFIED. BD WILL CONTINUE TO MONITOR FOR TRENDING. THE RISK TO THE END USER IS MINIMAL AS THE DISCREPANT DATE IS SHORTER THAN THE CORRECT DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML VIAL THERE WAS A DISCREPANCY IN THE EXPIRATION DATE ON THE VIALS AND COC PACKAGING LIST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS A DISCREPANCY IN THE EXPIRATION DATE ON THE VIALS AND COC PACKAGING LIST. CUSTOMER PROBLEM: UVT 220220 LABELING ISSUE - DISCREPANCY IN EXP DATE ON VIALS AND COC / PACKING LIST. CUSTOMER RESPONDED PROVIDING 2 PHOTOS - PLEASE SEE ATTACHED, AND THE FOLLOWING RESPONSES: LOT NUMBER AND EXPIRATION DATE PRINTED ON THE VIALS; LOT N030681 EXPIRATION 2022-04-30. LOT NUMBER AND EXPIRATION DATE PRINTED ON THE PACKING LIST; LOT N030681 EXPIRATION 2022-05-31. SEE ALSO ATTACHED COFC."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML VIAL THERE WAS A DISCREPANCY IN THE EXPIRATION DATE ON THE VIALS AND COC PACKAGING LIST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS A DISCREPANCY IN THE EXPIRATION DATE ON THE VIALS AND COC PACKAGING LIST. CUSTOMER PROBLEM: UVT 220220 LABELING ISSUE - DISCREPANCY IN EXP DATE ON VIALS AND COC / PACKING LIST. CUSTOMER RESPONDED PROVIDING 2 PHOTOS - PLEASE SEE ATTACHED, AND THE FOLLOWING RESPONSES: LOT NUMBER AND EXPIRATION DATE PRINTED ON THE VIALS; LOT N030681 EXPIRATION 2022-04-30 LOT NUMBER AND EXPIRATION DATE PRINTED ON THE PACKING LIST; LOT N030681 EXPIRATION 2022-05-31 SEE ALSO ATTACHED COFC"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951445 BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML VIAL CULTURE MEDIA, NON-PROPAGATING TRANSPORT JSM BECTON, DICKINSON & CO. (SPARKS) 220220 N03068100 30382902202203

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown