BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8283847 · Received January 28, 2019

    Report

    Report Number
    1710034-2019-00122
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 23, 2019
    Report Date
    March 15, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835370
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED A TOTAL OF 393 UNITS: 194 SEALED UNITS FROM LOT NUMBER 8172681 ON DISPENSERS/PLASTIC BAG. 199 SEALED UNITS FROM LOT NUMBER 8197833 ON DISPENSERS/PLASTIC BAG. 1 USED UNIT (CATHETER-ADAPTER EXTENSION SET) WITH NO PACKAGING MATERIAL. ACTUAL SAMPLE. UN-USED UNITS: 100% VISUAL EXAMINATION: NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED ON ANY OF THE COMPONENTS OF THE UNITS RECEIVED. THE EXTENSION TUBINGS WERE PROPERLY ADHERED TO THE WALL OF THE WINGED ADAPTERS . THE EXTENSION TUBINGS WERE MANUALLY PULLED IN AN ATTEMPT TO DISCONNECT IT FROM THE WINGED ADAPTER. THE TUBINGS STAYED CONNECTED AND DID NOT DISLODGED. USED UNIT: THE EXTENSION TUBING WAS DISCONNECTED FROM THE PORT OF THE WINGED ADAPTER. TRACES OF ADHESIVE RESIDUE WERE PRESENT ON THE OUTER RIM OF THE WING ADAPTER PORT. NO TRACES OF ADHESIVE WERE OBSERVED ON THE EXTENSION TUBING. CUSTOMER WAS UNSURE WHICH LOT THE ISSUE WAS WITH SO THE LOT NUMBER WILL BE CHOSEN AS UNKNOWN BUT A DHR WILL BE PERFORMED ON BOTH ALLEGED LOTS 8172681: THE LOT WAS BUILT / PACKAGED ON NFA LINE #1 FROM 26JUN2018 THROUGH 29JUN2018 FOR THE QUANTITY OF (B)(4) EA. NO QNS WERE INITIATED DURING PRODUCTION. ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED AND PASSED PER SPECIFICATIONS. 8197833: THE LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE #1 FROM 17JULY2018 THRU 19JULY2018. NO QNS WERE INITIATED DURING PRODUCTION. ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED AND PASSED PER SPECIFICATIONS. PROBABLE ROOT CAUSE-MANUFACTURING: CONCLUSION(S): THE MANUFACTURING DEPARTMENT IDENTIFIED THE ISSUE AND TOOK IMMEDIATE CORRECTIVE ACTION ON 11 SEP 2018 BY UPGRADING THE VISION SYSTEM ON BOTH PRODUCTION LINES TO BE ABLE TO DETECT ADHESIVE THAT WAS NOT IN THE CORRECT LOCATION. HOLDERS FOR THE ADHESIVE DISPENSE TIPS WERE ADDED TO THE MACHINE ON 26 SEP 2018 TO BETTER PROTECT THE TIPS FROM DAMAGE AND BECOMING MISALIGNED. CAPA 684099 HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER CONFIRMING FLASH BACK, THE EXTENSION TUBE OF A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM CAME OFF, RESULTED IN LEAKAGE.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 AFTER CONFIRMING FLASH BACK, THE EXTENSION TUBE OF A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM CAME OFF, RESULTED IN LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73474 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8172681 30382903835370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other