BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 10140630 · Received June 10, 2020

    Report

    Report Number
    1917413-2020-00489
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    April 3, 2020
    Report Date
    July 6, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD HAS BEEN UPDATED WITH ADDITIONAL INFORMATION: B.3. DATE OF EVENT: (B)(6) 2020.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR TUBE SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED. 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 DURING USE THE INNER TUBE WAS DIFFICULT TO REMOVE AND GREAT FORCE WAS USED TO REMOVE IT. THE INNER TUBE, HOWEVER, IS NOT MEANT TO BE REMOVED WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THERE IS A RISK OF SPLASHING OR ANOTHER OCCUPATIONAL ACCIDENT RELATED TO BLUE STOPPER TUBE WITH CITRATE, IT IS DIFFICULT TO REMOVE THE INNER TUBE, GREAT FORCE MUST BE APPLIED TO THE POINT OF DEFORMING THE EXTERNAL TUBE, BATCH 9260286 BRAND BD VACUTAINER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE INNER TUBE WAS DIFFICULT TO REMOVE AND GREAT FORCE WAS USED TO REMOVE IT. THE INNER TUBE, HOWEVER, IS NOT MEANT TO BE REMOVED WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THERE IS A RISK OF SPLASHING OR ANOTHER OCCUPATIONAL ACCIDENT RELATED TO BLUE STOPPER TUBE WITH CITRATE, IT IS DIFFICULT TO REMOVE THE INNER TUBE, GREAT FORCE MUST BE APPLIED TO THE POINT OF DEFORMING THE EXTERNAL TUBE, BATCH 9260286 BRAND BD VACUTAINER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE INNER TUBE WAS DIFFICULT TO REMOVE AND GREAT FORCE WAS USED TO REMOVE IT. THE INNER TUBE, HOWEVER, IS NOT MEANT TO BE REMOVED WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THERE IS A RISK OF SPLASHING OR ANOTHER OCCUPATIONAL ACCIDENT RELATED TO BLUE STOPPER TUBE WITH CITRATE, IT IS DIFFICULT TO REMOVE THE INNER TUBE, GREAT FORCE MUST BE APPLIED TO THE POINT OF DEFORMING THE EXTERNAL TUBE, BATCH 9260286 BRAND BD VACUTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605156 BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 9260286 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other