BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 11101039 · Received December 31, 2020

    Report

    Report Number
    1710034-2020-00843
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    November 23, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    UDI-DI
    00382903835560
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-14 H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION.  BD RECEIVED NINETEEN UNOPENED SHIPPER BOXES (1,520 UNITS IN TOTAL) FROM THE DISTRIBUTOR (OWENS & MINOR) TO BE INVESTIGATED UNDER PR¿S 2090830, 2105563, 2120568, 2135578, AND 2137283. TWO OPENED UNITS AND SIX PHOTOS WERE ALSO RECEIVED. SINCE THE NINETEEN BOXES OF UNITS WERE UNUSED, SEVENTY-SIX UNITS WERE RANDOMLY SELECTED FOR TESTING PER BD POLICY. THE UNITS WERE VISUALLY INSPECTED FOR ANY SIGNS OF DAMAGE TO THE TIP SHIELD, V-CLIP, AND ADAPTER PRIOR TO DECOUPLE. NO VISUAL DEFECTS WERE OBSERVED IN THE SEVENTY-SIX UNITS AND NO UNITS WERE FOUND TO HAVE PREMATURELY DECOUPLED. THE UNITS WERE THEN RETRACTED TO CHECK FOR FAILURE TO DECOUPLE. ONE UNIT FAILED TO DECOUPLE. NO UNITS WERE FOUND TO HAVE AN EXPOSED NEEDLE. DURING THE MICROSCOPIC EXAMINATION OF THE FAILED UNIT, IT WAS OBSERVED THAT DEFORMED PLASTIC FROM THE TIP SHIELD WAS PREVENTING THE V-CLIP FROM MOVING TO THE OPEN POSITION. THIS IN TURN PREVENTED THE NEEDLE ASSEMBLY FROM DECOUPLING FROM THE WINGED ADAPTER. BASED ON THE LOCATION OF THE DAMAGE, THE DEFECT MOST LIKELY ORIGINATED DURING THE MANUFACTURING PROCESS. AN ADDITIONAL SEVEN UNITS WERE ALSO FOUND TO HAVE DAMAGE TO THE TIP SHIELD. HOWEVER, THE PLASTIC DID NOT INTERFERE WITH DECOUPLING.   UPON INITIAL INSPECTION OF THE TWO OPENED UNITS, IT WAS IDENTIFIED THAT ONE UNIT WAS COMPLETELY RETRACTED BUT HAD NOT DECOUPLED FROM THE WINGED ADAPTER AND THE OTHER UNIT COULD BE PULLED STRAIGHT OFF THE WINGED ADAPTER WITHOUT PERFORMING RETRACTION. FURTHER INSPECTION OF THE OPENED UNIT THAT HAD NOT DECOUPLED REVEALED THAT THE SAME DAMAGE TO THE TIP SHIELD THAT WAS FOUND IN THE UNOPENED UNIT WAS ALSO PREVENTING THIS UNIT FROM DECOUPLING. THE SECOND OPENED UNIT WAS FURTHER INSPECTED AND FOUND TO HAVE DAMAGE WHICH PREVENTED THE TIP SHIELD FROM LATCHING ONTO THE BASE. THIS DAMAGE LIKELY OCCURRED DURING MANUFACTURING. THE PROVIDED PHOTOS WERE INSPECTED AND DETERMINED TO DISPLAY THE SAME DEFECTS OBSERVED IN THE TWO OPENED UNITS THAT WERE RECEIVED.   THE FAILURES OF FAILURE TO DECOUPLE AND PREMATURE DECOUPLING WERE CONFIRMED THROUGH THE INVESTIGATION. BD WAS ABLE TO IDENTIFY THE ROOT CAUSES AS MOST LIKELY ORIGINATING DURING MANUFACTURING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THIS BATCH. AS THE ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT WITH MAXZERO¿ NEEDLELESS CONNECTOR 20 GA 1.00 IN EXPERIENCED A BROKEN/DETACHED NEEDLE AND DIFFICULTY REMOVING THE SAFETY MECHANISM/NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 4 OF 6 MATERIAL NO: 383556 BATCH NO: 0014645 11/23/2020 - NEEDLE PULLED OUT OF THE HUB NEEDLE CAME OUT WHEN ATTEMPTING TO BREAK SEAL BETWEEN WHITE AND GRAY PIECE. WHITE SAFETY PIECE DID NOT ENGAGE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE BRAND NAME: BD NEXIVA" CLOSED IV CATHETER SYSTEM SINGLE PORT WITH MAXZERO" NEEDLELESS CONNECTOR 20 GA 1.00 IN A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA" CLOSED IV CATHETER SYSTEM - SINGLE PORT WITH MAXZERO" NEEDLELESS CONNECTOR 20 GA 1.00 IN EXPERIENCED A BROKEN/DETACHED NEEDLE AND DIFFICULTY REMOVING THE SAFETY MECHANISM/NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 4 OF 6 MATERIAL NO: 383556, BATCH NO: 0014645. (B)(6) 2020 - NEEDLE PULLED OUT OF THE HUB. NEEDLE CAME OUT WHEN ATTEMPTING TO BREAK SEAL BETWEEN WHITE AND GRAY PIECE. WHITE SAFETY PIECE DID NOT ENGAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564196 SEE H10 INTRAVASCULAR CATHETER FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0014645 00382903835560

    Patients

    Seq Age Sex Outcome Treatment
    1