BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20 GA X 1.00IN SP WITH MAXZERO

    MDR report key: 11032565 · Received December 17, 2020

    Report

    Report Number
    1710034-2020-00805
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 2, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835561
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    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 ((B)(4)UNITS IN TOTAL) FROM THE DISTRIBUTOR (OWENS & MINOR) TO BE INVESTIGATED UNDER PR¿S (B)(4). 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 A NEXIVA 20 GA X 1.00IN SP WITH MAXZERO HAD A SAFETY MECHANISM THAT WOULD NOT DISENGAGE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE THE NEEDLE WOULD DETACH FROM THE UNIT, THE CATHETER DISENGAGES WHEN THE SAFETY IF FULLY ACTIVATED, CATHETER FALLING OFF LEAVING THE NEEDLE EXPOSED AND THE CATHETER WOULD NOT DISENGAGE FROM THE SAFETY DEVICE (AND NEEDLE) AFTER PLACED IN THE PATIENT. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: SIS HAVE BEEN PLACED FOR ALL MALFUNCTIONS, BUT I WANTED TO LET YOU KNOW THIS WAS THE THIRD IV WITH THIS ISSUE. DO WE NEED TO ESCALATE ANY FURTHER? THE ERROR IS AT THE SAFETY FEATURE WITH THE CATHETER AND IV SAFETY (CATHETER DISENGAGES NORMALLY WHEN SAFETY IS FULLY ACTIVATED). WE HAVE HAD TWO CATHETERS FALL OFF, EXPOSING THE NEEDLE AND ONE IN WHICH THE CATHETER WOULD NOT DISENGAGE FROM THE SAFETY DEVICE (AND NEEDLE) AFTER PLACED IN THE PATIENT. . I HAVE RECEIVED TWO OTHER REPORTS ON THIS PRODUCT IN THE LAST FEW WEEKS. I HAVE NOT RECEIVED ANY SI'S SINCE (B)(6) . THE LOT # ON THE PICTURE BELOW MATCHES THE LOT # FROM 11/2. HAVE WE HAD FURTHER ISSUES ON THIS PRODUCT TODAY? (B)(6). SI-83792. PRE/POST: NURSE WAS LOOSENING THE CATHETER AND THE NEEDLE CAME STICKING STRAIGHT OUT THE BACKSIDE ON ITS OWN. (B)(6). SI-83509. PRE/POST: AFTER IV INSERTION, THE NEEDLE WOULD NOT DETACH FROM THE UNIT THE ONLY PRODUCT I HAVE ISSUES ON IS THE #S457756. TWO OF THE LOT #S MATCH, SO IT MAY ONLY BE THAT ONE SIZE. "

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEXIVA 20 GA X 1.00IN SP WITH MAXZERO HAD A SAFETY MECHANISM THAT WOULD NOT DISENGAGE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE WOULD DETACH FROM THE UNIT, THE CATHETER DISENGAGES WHEN THE SAFETY IF FULLY ACTIVATED, CATHETER FALLING OFF LEAVING THE NEEDLE EXPOSED AND THE CATHETER WOULD NOT DISENGAGE FROM THE SAFETY DEVICE (AND NEEDLE) AFTER PLACED IN THE PATIENT. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: SIS HAVE BEEN PLACED FOR ALL MALFUNCTIONS, BUT I WANTED TO LET YOU KNOW THIS WAS THE THIRD IV WITH THIS ISSUE. DO WE NEED TO ESCALATE ANY FURTHER? THE ERROR IS AT THE SAFETY FEATURE WITH THE CATHETER AND IV SAFETY (CATHETER DISENGAGES NORMALLY WHEN SAFETY IS FULLY ACTIVATED). WE HAVE HAD TWO CATHETERS FALL OFF, EXPOSING THE NEEDLE AND ONE IN WHICH THE CATHETER WOULD NOT DISENGAGE FROM THE SAFETY DEVICE (AND NEEDLE) AFTER PLACED IN THE PATIENT. . I HAVE RECEIVED TWO OTHER REPORTS ON THIS PRODUCT IN THE LAST FEW WEEKS. I HAVE NOT RECEIVED ANY SI'S SINCE 11/9. THE LOT # ON THE PICTURE BELOW MATCHES THE LOT # FROM 11/2. HAVE WE HAD FURTHER ISSUES ON THIS PRODUCT TODAY? 11/9 SI-83792. PRE/POST: NURSE WAS LOOSENING THE CATHETER AND THE NEEDLE CAME STICKING STRAIGHT OUT THE BACKSIDE ON ITS OWN. 11/2 SI-83509. PRE/POST: AFTER IV INSERTION, THE NEEDLE WOULD NOT DETACH FROM THE UNIT THE ONLY PRODUCT I HAVE ISSUES ON IS THE #S457756. TWO OF THE LOT #S MATCH, SO IT MAY ONLY BE THAT ONE SIZE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498320 NEXIVA 20 GA X 1.00IN SP WITH MAXZERO INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383556 0014645 30382903835561

    Patients

    Seq Age Sex Outcome Treatment
    1