BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 10907373 · Received November 26, 2020

    Report

    Report Number
    1917413-2020-01185
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    October 30, 2020
    Report Date
    April 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903672900
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN CORRECTED: B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER THERE WAS AN ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED "THE ADAPTER BROKE OFF INSIDE THE LUMEN. A USER FACILITY DIALYSIS TECHNICIAN REPORTED THAT THE ADAPTER BROKE OFF INSIDE OF THE LUMEN. ALL ATTEMPTS TO REMOVE IT ONLY BROKE IT DOWN EVEN FURTHER." PATIENT HAD TO BE SENT TO THE ER FOR EVALUATION OF CENTRAL VENOUS CATHETER (CVC). CVC WAS ULTIMATELY REPLACED BY SURGEON. D1: MEDICAL DEVICE BRAND NAME: BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER D2A: COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE D2B: MEDICAL DEVICE TYPE OR (PROCODE) : JKA. D4 CATALOG #: 367290. D4. MEDICAL DEVICE LOT#: 0156058. D4 UDI: (B)(4). G5. PMA/510K INFO: K991088. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2023. H4. DEVICE MANUFACTURE DATE: 04-JUN-2020. H6. INVESTIGATION SUMMARY: BD RECEIVED TEN (10) SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR DAMAGED WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THIS BATCH 0156058. ALL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS. THERE WERE NO QNS OR NCMRS ASSOCIATED WITH THIS BATCH. BD SUMTER RECEIVED 10 BD LUER ADAPTER DEVICES. THE SAMPLES WERE SUBJECTED TO A TORQUE FORCE TEST IN ORDER TO TEST THE HUB STRENGTH. ALL 10 SAMPLES PASSED THE TEST AND MET SPECIFICATION REQUIREMENTS. THE MINIMUM FORCE REQUIRED TO BREAK THE HUB AS STATED IN VS50004 IS 2.5LBS. THE 10 SAMPLES TESTED WITH FORCES RANGING FROM 2.95-5.16LBS. BASED ON THE CUSTOMER SAMPLES AND INVESTIGATION RESULTS, BD IS UNABLE TO CONFIRM THE CUSTOMER¿S REPORTED FAILURE MODE OF A BROKEN DEVICE AS WE WERE UNABLE TO DUPLICATE THE REPORTED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER THERE WAS AN ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED "THE ADAPTER BROKE OFF INSIDE THE LUMEN. A USER FACILITY DIALYSIS TECHNICIAN REPORTED THAT THE ADAPTER BROKE OFF INSIDE OF THE LUMEN. ALL ATTEMPTS TO REMOVE IT ONLY BROKE IT DOWN EVEN FURTHER." PATIENT HAD TO BE SENT TO THE ER FOR EVALUATION OF CENTRAL VENOUS CATHETER (CVC). CVC WAS ULTIMATELY REPLACED BY SURGEON.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS AN ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED "THE ADAPTER BROKE OFF INSIDE THE LUMEN. A USER FACILITY DIALYSIS TECHNICIAN REPORTED THAT THE ADAPTER BROKE OFF INSIDE OF THE LUMEN. ALL ATTEMPTS TO REMOVE IT ONLY BROKE IT DOWN EVEN FURTHER." PATIENT HAD TO BE SENT TO THE ER FOR EVALUATION OF CENTRAL VENOUS CATHETER (CVC). CVC WAS ULTIMATELY REPLACED BY SURGEON.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS AN ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED "THE ADAPTER BROKE OFF INSIDE THE LUMEN. A USER FACILITY DIALYSIS TECHNICIAN REPORTED THAT THE ADAPTER BROKE OFF INSIDE OF THE LUMEN. ALL ATTEMPTS TO REMOVE IT ONLY BROKE IT DOWN EVEN FURTHER." PATIENT HAD TO BE SENT TO THE ER FOR EVALUATION OF CENTRAL VENOUS CATHETER (CVC). CVC WAS ULTIMATELY REPLACED BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374439 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 366430 0156058 50382903672900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other