BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    MDR report key: 9812227 · Received March 10, 2020

    Report

    Report Number
    1024879-2020-00187
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    February 16, 2020
    Report Date
    April 15, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K011984
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND LEAKAGE 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS) LAST THURSDAY I RECEIVED A CALL FROM THE SENIOR PHLEBOTOMY TO INFORM ME THAT THERE ARE INCIDENTS OF THE LEAKAGE OF BLOOD FROM THE TRANSLUCENT BODY AND SOME FROM THE MULTI SAMPLE SLEEVE NEEDLE FROM INSIDE THE HOLDER ITS HAPPENED SEVERAL TIMES WITH 21G & 23G WITH THE DIFFERENT PHLEBOTOMIST. THEY WERE CONTAMINATED WITH THE PATIENTS BLOOD AND THE PATIENT AS WELL. THE ACTION WAS TAKEN ON SUNDAY I VISIT THEM TO OBSERVE THEM DURING THE BLOOD COLLECTION AND NOTICED DROPS OF BLOOD INSIDE THE HOLDER IN SOME CASES WITH THE DIFFERENT PHLEBOTOMIST AND LEAKAGE AS SHOWN IN PICTURES, THE OBSERVATION PROCESS IS STILL UNDER PROCESS TO CONFIRM THE PROBLEM.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: FMI & JKA. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9084948. MEDICAL DEVICE EXPIRATION DATE: 2021-03-31. DEVICE MANUFACTURE DATE: 2019-03-25. MEDICAL DEVICE LOT #: 9150619. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2019-05-30. MEDICAL DEVICE LOT #: 9196974. MEDICAL DEVICE EXPIRATION DATE: 2021-07-31. DEVICE MANUFACTURE DATE: 2019-07-15." 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 LEAKAGE OCCURRED DURING USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS.) LAST THURSDAY I RECEIVED A CALL FROM THE SENIOR PHLEBOTOMY TO INFORM ME THAT THERE ARE INCIDENTS OF THE LEAKAGE OF BLOOD FROM THE TRANSLUCENT BODY AND SOME FROM THE MULTI SAMPLE SLEEVE NEEDLE FROM INSIDE THE HOLDER ITS HAPPENED SEVERAL TIMES WITH 21G & 23G WITH THE DIFFERENT PHLEBOTOMIST. THEY WERE CONTAMINATED WITH THE PATIENTS BLOOD AND THE PATIENT AS WELL. THE ACTION WAS TAKEN ON SUNDAY I VISIT THEM TO OBSERVE THEM DURING THE BLOOD COLLECTION AND NOTICED DROPS OF BLOOD INSIDE THE HOLDER IN SOME CASES WITH THE DIFFERENT PHLEBOTOMIST AND LEAKAGE AS SHOWN IN PICTURES, THE OBSERVATION PROCESS IS STILL UNDER PROCESS TO CONFIRM THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278312 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE FMI BECTON, DICKINSON & CO., (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other