BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 8872092 · Received August 7, 2019

    Report

    Report Number
    1024879-2019-01378
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 19, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673440
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. THE SAMPLES WERE TESTED FOR TUBING/COMPONENT LEAKAGE UNDER PRESSURIZED CONDITIONS AND DRAW TESTED FOR INSUFFICIENT FILLING OF THE TUBES, AND ALL SAMPLES MET SPECIFICATIONS. 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA #764355 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET EXPERIENCED FAILURE TO CONTAIN BLOOD OR MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367344, BATCH NO. 8253781. BLOOD LEAKING FROM PUSH BUTTON WINGSET- 21G. USED GREEN 21 G BUTTERFLY NEEDLE. DIDN'T SEE ANY DEFECT, ON BLOOD RETURN, COULDN'T GET BLOOD TO FLOW IN VACUTAINER AND TUBE. NOTED TO DRIP FROM TUBING RIGHT ABOVE HUB TO CONNECT TO SYRINGE OR VACUTAINER. LOT # 8253781, EXP 9/30/2020.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: JKA, FPA. 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® PUSH BUTTON BLOOD COLLECTION SET EXPERIENCED FAILURE TO CONTAIN BLOOD OR MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367344, BATCH NO. 8253781. BLOOD LEAKING FROM PUSH BUTTON WINGSET- 21G. USED GREEN 21 G BUTTERFLY NEEDLE. DIDN'T SEE ANY DEFECT, ON BLOOD RETURN, COULDN'T GET BLOOD TO FLOW IN VACUTAINER AND TUBE. NOTED TO DRIP FROM TUBING RIGHT ABOVE HUB TO CONNECT TO SYRINGE OR VACUTAINER. LOT # 8253781, EXP 9/30/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666518 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET JKA BECTON, DICKINSON & CO., (BD) 8253781 50382903673440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other