BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 8440528 · Received March 21, 2019

    Report

    Report Number
    1024879-2019-00635
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 27, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903672900
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: 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 BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER HAD LEAKAGE. THE FOLLOWING WAS REPORTED, " MATERIAL NO: 367290 BATCH NO: 8200718 IT WAS REPORTED THE RUBBER IS SHIFTING OFF OF THE NEEDLE CAUSING BLOOD TO COME OUT OF THE NEEDLE. IT HAS BEEN BROUGHT TO MY ATTENTION THAT WE¿VE HAD SOME DIFFICULTY WITH THE BD VACUTAINER MULTIPLE SAMPLE LUER ADAPTER IN THE PAST WEEK. IT APPEARS THAT THE RUBBER IS SHIFTING OFF OF THE NEEDLE CAUSING BLOOD TO COME OUT OF THE NEEDLE. I KNOW OF 3 INCIDENTS OF THIS HAPPENING AND IF YOU CAN IMAGINE IT CAUSES QUITE THE MESS AS THERE¿S NOTHING TO KEEP THE BLOOD FROM COMING OUT OF THE NEEDLE IF THE RUBBER IS NOT COVERING IT." THIS OCCURRED ON 6 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    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 A BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER HAD LEAKAGE. THE FOLLOWING WAS REPORTED, "MATERIAL NO: 367290; BATCH NO: 8200718. IT WAS REPORTED THE RUBBER IS SHIFTING OFF OF THE NEEDLE CAUSING BLOOD TO COME OUT OF THE NEEDLE. IT HAS BEEN BROUGHT TO MY ATTENTION THAT WE¿VE HAD SOME DIFFICULTY WITH THE BD VACUTAINER MULTIPLE SAMPLE LUER ADAPTER IN THE PAST WEEK. IT APPEARS THAT THE RUBBER IS SHIFTING OFF OF THE NEEDLE CAUSING BLOOD TO COME OUT OF THE NEEDLE. I KNOW OF 3 INCIDENTS OF THIS HAPPENING AND IF YOU CAN IMAGINE IT CAUSES QUITE THE MESS AS THERE¿S NOTHING TO KEEP THE BLOOD FROM COMING OUT OF THE NEEDLE IF THE RUBBER IS NOT COVERING IT." THIS OCCURRED ON 6 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235357 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 8200718 50382903672900

    Patients

    Seq Age Sex Outcome Treatment
    1 Other