BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8112892 · Received November 28, 2018

    Report

    Report Number
    1710034-2018-00841
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    October 26, 2018
    Report Date
    January 21, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K111366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A VIDEO WAS SUBMITTED FOR REVIEW. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF SEPARATION INSERTER FROM TUBING WITH LOT #8170921 REGARDING ITEM #383539. DHR REVIEW WAS PERFORMED ON LOT NUMBER 8170921 (NEXIVA). THE LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE 1 FROM 20JUN18 THRU 26JUN18. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED SIX QNS 200756999 (INCOMPLETE SEAL), 200757027 (SPLICE TAPE), 200756998 (FOREIGN (OIL), 200757026 (ILLEGIBLE PRINT), 200757212 (TD NOT FOLLOWED) AND 200757213 (RUNNING AT RISK) WERE INITIATED DURING THE BUILD OF THIS LOT THAT WOULD NOT IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. DHR REVIEWS WERE PERFORMED ON SUB-ASSEMBLY LOT NUMBERS FOR THE Q-SYTE UNITS: 8103526 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 4, FROM 16APR2018 THRU 18APR2018. 8106532 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 1, FROM 21APR2018 THRU 23APR2018. 8106534 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 1, FROM 23APR2018 THRU 28APR2018. 8131921 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 1, FROM 14MAY2018 THRU 17MAY2018. 8131923 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2, FROM 15MAY2018 THRU 17MAY2018. 8075552 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 4, FROM 28MAR2018 THRU 30MAR2018. 8082902 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 4, FROM 30MAR2018 THRU 03APR2018 8082897 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2, FROM 25MAR2018 THRU 27MAR2018. 8085935 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2, FROM 28MAR2018 THRU 31MAR2018. REVIEW SUB ASSEMBLY LOT NUMBER DHR¿S REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THESE LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. NO QUALITY NOTIFICATIONS WERE INITIATED DURING THE BUILD OF THESE SUB ASSEMBLY LOT NUMBERS. INVESTIGATION CONCLUSION: BASED ON THE REVIEW OF THE SUBMITTED VIDEO, THE DEFECT SEPARATION INSERTER FROM TUBING WAS NOT CONFIRMED. THE ISSUE WAS WITH THE Q-SYTE UNIT; WHICH LOOKED TO BE SEPARATE AT THE WELD JOINT LOCATION. ROOT CAUSE DESCRIPTION: WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. RATIONALE: A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED MONTHLY. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM BROKE AT THE Q-SYTE WHEN DISCONNECTING THE TUBING.

    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 NEXIVA¿ CLOSED IV CATHETER SYSTEM BROKE AT THE Q-SYTE WHEN DISCONNECTING THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949209 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8170921 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other