BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 9255290 · Received October 30, 2019

    Report

    Report Number
    1024879-2019-01876
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 14, 2019
    Report Date
    January 28, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOTS 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 H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACATIONER® PUSH BUTTON BLOOD COLLECTION SET LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367342 , BATCH NO. POSSIBLE 9213764 OR 9150585. IT WAS REPORTED THAT THERE LEAKAGE FROM THE NEEDLE HUB. THE CUSTOMER REPORTED AN ISSUE WITH LEAKAGE, THE PATIENT HAD TO BE DRAWN. NO FURTHER ISSUES REPORTED. NO PATIENT IDENTIFIERS ARE AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDICAL DEVICE TYPE: FPA. ADDITIONAL COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9150585. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2019-05-30. MEDICAL DEVICE LOT #: 9213764. MEDICAL DEVICE EXPIRATION DATE: 2021-07-31. DEVICE MANUFACTURE DATE: 2019-08-01. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367342, BATCH NO. POSSIBLE 9213764 OR 9150585. IT WAS REPORTED THAT THERE LEAKAGE FROM THE NEEDLE HUB. THE CUSTOMER REPORTED AN ISSUE WITH LEAKAGE, THE PATIENT HAD TO BE DRAWN. NO FURTHER ISSUES REPORTED. NO PATIENT IDENTIFIERS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052548 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367342 SEE H.10 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other