BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BLOOD COLLECTION TUBES

    MDR report key: 7419727 · Received April 10, 2018

    Report

    Report Number
    1917413-2018-00724
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    November 8, 2016
    Report Date
    June 9, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679213
    PMA / PMN Number
    K901449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE PMA / 510(K) NUMBERS REPORTED TO BE INVOLVED. THE ORIGINAL MDR INCLUDED THE INFORMATION FOR #K901449. THE CORRECTION IS MADE TO INCLUDE THE ADDITIONAL PMA / 510(K) NUMBER: PMA / 510(K)#: K945952.

    Additional Manufacturer Narrative · 1

    RESULTS -SAMPLE WAS RECEIVED AT BD (B)(4). (B)(4) RECEIVED USED SAMPLE AND CONFIRMED THAT THERE WAS A 13 MM SIZE FM LIKE CHIP OF PLASTIC IN THE TUBE. THIS COMPLAINT IS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. CONCLUSION ¿ BD PAS ACKNOWLEDGES THAT THE CUSTOMER HAS HAD AN ISSUE WITH THE INCIDENT LOT. BASED ON THE SEVERITY AND OCCURRENCE OF THE REPORTED CONDITION THERE WILL BE NO FURTHER ACTIONS. INVESTIGATION CONFIRMED PIC (B)(4) (FOREIGN MATTER - PROCESS) WAS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BLOOD OF A BD VACUTAINER® SODIUM FLUORIDE 5MG POTASSIUM OXALATE 4 MG (FX) BLOOD COLLECTION TUBES. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254202 BD VACUTAINER® BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6064589 50382903679213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other