BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® THROMBIN PLUS BLOOD COLLECTION TUBES

    MDR report key: 9500627 · Received December 20, 2019

    Report

    Report Number
    9617032-2019-01519
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    June 6, 2018
    Report Date
    February 21, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. DATE RECEIVED BY MANUFACTURER: 2019-07-18. BD HAS UPDATED THE AWARENESS DATE TO JULY 18, 2019, SINCE THIS DATE REPRESENTS A CORRECTED TIME-FRAME FOR WHEN BD REVIEWED THE INTERNAL TEST DATA AND CAME TO THE CONCLUSION THAT TESTING HAD NOT MET SPECIFICATIONS. THE INITIAL AWARENESS DATE THAT WAS REFERENCED IN THE COMPLAINT, REPRESENTED THE DATE THAT THE TESTING WAS CONDUCTED. H.6. INVESTIGATION SUMMARY BD HAD PERFORMED AN EVALUATION OF THE COMPLAINT AND OBSERVED THE FAILURE MODE BASED ON THE RESULTS GENERATED DURING INTERNAL TESTING. ADDITIONALLY, THE INCIDENT LOT HAD EXPIRED AT THE TIME THIS ISSUE WAS BEING EVALUATED SO NO FURTHER TESTING COULD BE PERFORMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® THROMBIN PLUS BLOOD COLLECTION TUBE DID NOT MEET THE PRODUCT SPECIFICATION OF "0.7 LBS" FOR STOPPER PULLOUT FORCES DURING TESTING. THE TUBES WERE TESTED AS PART OF CAPA# 54720 AND STERILIZED AT "NOMINAL (~22.8 KG) AND MAXIMUM DOSE LEVELS (~38.4 KGY)". THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PART OF CAPA 54720, WE SOURCED BD VACUTAINER® THROMBIN TUBE 4.8 ML (367817) TUBES WHICH WERE STERILIZED AT NOMINAL (~22.8 KGY) AND MAXIMUM DOSE LEVELS (~38.4 KGY) FOR 2ND STOPPER PULLOUT FORCE. THE TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER® THROMBIN TUBE 4.8 ML TUBES DID NOT MEET THE PRODUCT SPECIFICATION OF 0.7 LBS FOR EACH INDIVIDUAL VALUES OF 2ND STOPPER PULLOUT FORCE FOR BELOW LISTED TEST INTERVALS. THE NOMINAL AND MAXIMUM DOSE TEST SAMPLES FOR THE 4.8 ML WERE FROM LOT # 8029635.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THE BD VACUTAINER® THROMBIN PLUS BLOOD COLLECTION TUBE DID NOT MEET THE PRODUCT SPECIFICATION OF "0.7 LBS" FOR STOPPER PULLOUT FORCES DURING TESTING. THE TUBES WERE TESTED AS PART OF CAPA# (B)(4) AND STERILIZED AT "NOMINAL (~22.8 KG) AND MAXIMUM DOSE LEVELS (~38.4 KGY)". THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PART OF CAPA (B)(4), WE SOURCED BD VACUTAINER® THROMBIN TUBE 4.8 ML (367817) TUBES WHICH WERE STERILIZED AT NOMINAL (~22.8 KGY) AND MAXIMUM DOSE LEVELS (~38.4 KGY) FOR 2ND STOPPER PULLOUT FORCE. THE TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER® THROMBIN TUBE 4.8 ML TUBES DID NOT MEET THE PRODUCT SPECIFICATION OF 0.7 LBS FOR EACH INDIVIDUAL VALUES OF 2ND STOPPER PULLOUT FORCE FOR BELOW LISTED TEST INTERVALS. THE NOMINAL AND MAXIMUM DOSE TEST SAMPLES FOR THE 4.8 ML WERE FROM LOT # 8029635.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302461 BD VACUTAINER® THROMBIN PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 8029635

    Patients

    Seq Age Sex Outcome Treatment
    1 Other