BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8242114 · Received January 11, 2019

    Report

    Report Number
    1710034-2018-00992
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 27, 2018
    Report Date
    March 18, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835165
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR: LOT WAS BUILT AND PACKAGED ON NFA LINE 1 FROM 05OCT2018 THROUGH 14OCT2018 FOR THE QUANTITY OF (B)(4) EA. ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. THERE WERE EIGHT QN¿S INITIATED FOR THIS LOT. THERE WERE SIX IP QNS AND TWO FG QNS INITIATED FOR THIS LOT, OF WHICH 2 ((B)(4)) WERE POTENTIALLY RELEVANT TO THE REPORTED DEFECT OF NEEDLE RETRACTION FAILURE ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT. (IP QN: (B)(4) - ¿MISSING CHALLENGE¿ PKG. INSPECTION PERFORMED BUT FAILED TO RECOVER RESULTS), (IP QN: (B)(4) -¿DIFFICULT RETRACTION¿), (IP QN: (B)(4) - ¿CANISTER INSERTION DEPTH OOS¿), (IP QN: (B)(4) - ¿RUNNING AT RISK¿ MOLDING QA HOLD TAG-MOISTURE TEST VERIFICATION), (IP QN: (B)(4) - ¿SUSPECT MISSING TIP¿), (IP QN: (B)(4) - ¿DIFFICULT RETRACTION¿), (FG QN: (B)(4) -¿P35-P37 CANISTER INSERTION OOS¿), (FG QN: (B)(4) -¿QN¿D NON RELEASED PRODUCT SHIPPED TO DC¿). WERE CURRENTLY STILL OPEN DURING THIS DHR. RECEIVED TWO UNUSED REPRESENTATIVE 20GA BD NEXIVA CLOSED IV CATHETER SYSTEM-SINGLE PORT UNITS WITHIN UNDAMAGED SEALED PACKAGES FROM LOT 8278516. THE UNITS WERE WITH ALL COMPONENTS PRESENT AND INTACT. VISUAL/MICROSCOPIC EVALUATION - (METHOD-N/A): UNITS: CONFIRMED THERE WERE NO SIGNS OF DAMAGE TO ANY AREA OF THE UNITS. CONFIRMED THE UNITS HAD NO SIGNS OF CURED ADHESIVE IN THE AREAS OF THE GRIP, TIP SHIELD OR WINGED ADAPTER AND THERE WAS NO DAMAGE THE RETAINING WASHER; ALL OF WHICH COULD RESULT IN HINDERING THE UNITS FROM DISENGAGING. THERE WERE NO SIGNS OF DAMAGE TO THE V-CLIP OR TIP SHIELD; OF WHICH COULD BE INDICATIONS OF FAILURE TO DECOUPLE. REMOVED THE PROTECTIVE NEEDLE COVERS; THERE WERE NO ANOMALIES OR DAMAGE (I.E. BENDS, KINKS, WRINKLES, ETC.) TO THE NEEDLES OR CATHETERS. FUNCTIONAL (NEEDLE DISENGAGEMENT AND DECOUPLING OF UNITS) (METHOD-N/A): GRIPPED THE FINGER GRIP BETWEEN THE THUMB AND INDEX FINGER WHILE HOLDING THE UNIT BY THE WINGED ADAPTER WITH THE OTHER HAND AND PULLED THE NEEDLE BACK THROUGH THE RETAINING WASHER AND INTO THE TIP SHIELD. THE NEEDLES EASILY PULLED BACK WITHOUT RESISTANCE UNTIL THE NEEDLE TIP SECURED WITHIN THE TIP SHIELD, AT TIME OF DISENGAGEMENT THE CATHETER/ADAPTER SEPARATED (DECOUPLING) FROM THE NEEDLE/GRIP: THUS CONFIRMING A SUCCESSFUL DISENGAGEMENT AND DECOUPLING CONFIRMED THERE WAS NO DAMAGE OR TRACES OF ADHESIVE IN THE AREAS OF THE COMPONENTS THAT COULD RESULT IN DECOUPLING ISSUES. PUSHED THE NEEDLES TO THE OUT POSITON; NO DAMAGE WAS OBSERVED. CONFIRMATION OF THE REPORTED DEFECTS OF (1) NEEDLE DIFFICULT DISENGAGEMENT AND (2) FAILURE TO DECOUPLE, WAS INCONCLUSIVE BASED ON THE OBSERVATION AND TESTING CONDUCTED ON THE UNITS PROVIDED FOR THIS INCIDENT. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESSES RELATED ISSUES FOR REPORTED DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM NEEDLE WAS NOT RETRACTING AND GETTING STUCK IN THE SEPTUM. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM NEEDLE WAS NOT RETRACTING AND GETTING STUCK IN THE SEPTUM. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35386 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8278516 30382903835165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other