BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD RNA TUBE

    MDR report key: 8575851 · Received May 2, 2019

    Report

    Report Number
    9617032-2019-00539
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 23, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    NTW
    PMA / PMN Number
    DEN050003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR GLASS BREAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR GLASS BREAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 40 PAXGENE® BLOOD RNA TUBE EXPERIENCED GLASS BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 762165, BATCH NO. 8081587. RCVD CALL FROM: CUST STATED SHE IS EXPERIENCING CRACKING OF TUBES AFTER USE, WORKERS WERE EXPOSED TO BLOOD BUT NO TESTING WAS DONE. CUSTOMER DOES HAVE PHOTOS SHE WILL EMAIL AS WELL AS PRODUCTS TO SEND OUT WHEN SHE RCVS FEDEX LABELS. THERE WAS 2 DATES OF OCCURRENCES (B)(6) 2019 (20) AND (B)(6) 2019 (40). SAME INFORMATION FOR BOTH DATES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 40 PAXGENE® BLOOD RNA TUBE EXPERIENCED GLASS BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 762165, BATCH NO. 8081587. RCVD CALL FROM: CUST STATED SHE IS EXPERIENCING CRACKING OF TUBES AFTER USE, WORKERS WERE EXPOSED TO BLOOD BUT NO TESTING WAS DONE. CUSTOMER DOES HAVE PHOTOS SHE WILL EMAIL AS WELL AS PRODUCTS TO SEND OUT WHEN SHE RCVS (B)(6) LABELS. THERE WAS 2 DATES OF OCCURRENCES (B)(6) 2019 (20) AND (B)(6) 2019 (40). SAME INFORMATION FOR BOTH DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369625 PAXGENE® BLOOD RNA TUBE RNA PREANALYTICAL SYSTEMS NTW BECTON, DICKINSON AND COMPANY (BD) 8081587

    Patients

    Seq Age Sex Outcome Treatment
    1 Other