BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9905326 · Received March 31, 2020

    Report

    Report Number
    1024879-2020-00241
    Event Type
    Malfunction
    Date Received
    March 31, 2020
    Date of Event
    March 11, 2020
    Report Date
    April 30, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/25/2020. H.6. INVESTIGATION: SIX CUSTOMER PHOTOS WERE RECEIVED FOR REVIEW AND ANALYSIS. UPON REVIEW OF THE PHOTOS, THERE APPEARS TO BE ONE BD PBBCS UNIT SHOWING LEAKAGE. BASED ON THE CLARITY OF THE PHOTO, IT IS UNABLE TO BE DETERMINED IF THERE IS ANY DAMAGE TO THE TUBING ON THE PBBCS UNIT OR IF ANY OTHER PART OF THE PBBCS UNIT IS DAMAGED. IN ADDITION, BD SUMTER RECEIVED 6 PHYSICAL SAMPLES FOR BATCHES 9150619 AND 9196974. THE SAMPLES WERE SUBJECTED TO A SUBMERGED LEAK TEST AND A THOROUGH VISUAL INCLUDING ONE FOR CUT TUBING. ALL SAMPLES PASSED THE TESTS AND NO DEFECTS WERE FOUND ON THE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE TWO REPORTED BATCH 9150619 AND 9196974 AND NO ISSUES WERE FOUND. PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS. ALL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS. NO QUALITY NOTIFICATION OR NON CONFORMANCE WERE RAISED ON THE REPORTED BATCH. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTOS PROVIDED. BASED ON A REVIEW OF BATCH RECORDS, NO ROOT CAUSE FROM MANUFACTURING WAS IDENTIFIED AS A CONTRIBUTOR. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR MONITORING OF CURRENT TRENDS. IF A COMPLAINT TREND WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAD BLOOD SPLATTER/LEAKAGE OR OTHER SAMPLE LEAKAGE FROM DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE OF BLOOD FROM THE TRANSLUCENT BODY AND SOME FROM THE MULTI-SAMPLE SLEEVE NEEDLE FROM INSIDE THE HOLDER'.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: 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 DURING USE THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAD BLOOD SPLATTER/LEAKAGE OR OTHER SAMPLE LEAKAGE FROM DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE OF BLOOD FROM THE TRANSLUCENT BODY AND SOME FROM THE MULTI-SAMPLE SLEEVE NEEDLE FROM INSIDE THE HOLDER'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372026 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