BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM)

    MDR report key: 9489815 · Received December 18, 2019

    Report

    Report Number
    1710034-2019-01339
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    December 3, 2019
    Report Date
    January 21, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD RECEIVED ONE UNUSED NEEDLE WITH THE ORIGINAL TOP WEBBING. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE RETRACTION FAILURE WITH LOT #9233236 REGARDING ITEM #383536. THROUGH THE INVESTIGATION, OUR QUALITY ENGINEER ATTEMPTED TO RECREATE THE EVENT. THE CANNULA WAS WITHDRAWN SLIGHTLY. A SCRAPING NOISE WAS OBSERVED WHICH REVEALED THE WASHER AND THE NEEDLE FRICTION WAS THE CAUSE. THE UNIT WAS DISSECTED. A BURR WAS OBSERVED WHICH WAS FOUND TO BE THE CAUSE OF THE INCREASE IN FRICTION. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL EVIDENCE TO CONFIRM AND SUPPORT A RAW MATERIAL RELATED ISSUE ALONG WITH AN OPERATOR ERROR DURING THE INSPECTION PROCESS. THE ROOT CAUSE OF THE DEFECT WAS DETERMINED TO BE THE RAW MATERIAL AND THAT THE PROPER INSPECTION OF INCOMING PRODUCT WAS NOT PERFORMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM) EXPERIENCED SAFETY MECHANISM/NEEDLE DISENGAGEMENT (REMOVAL) DIFFICULT PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 383536 BATCH NO.9233236 A FEW WEEKS BACK A FEW NEXIVA 20 GA. CATHETERS WERE HAVING ISSUES WITH THE NEEDLE GETTING STUCK WHILE BEING RETRACTED. ANOTHER IV LANDED ON MY DESK THAT HAS NOT BEEN PLACED IN A PATIENT, AS THE NURSE CHECKED THE NEEDLE TO ENSURE IT WOULD WITHDRAW AND FOUND IT TO BE ROUGH. IT IS HARDER TO PULL THIS NEEDLE BACK AND MAKES A SCRAPING NOISE. LOT #9233236.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 AN UNSPECIFIED NUMBER OF BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM) EXPERIENCED SAFETY MECHANISM/NEEDLE DISENGAGEMENT (REMOVAL) DIFFICULT PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 383536, BATCH NO.9233236. A FEW WEEKS BACK A FEW NEXIVA 20 GA. CATHETERS WERE HAVING ISSUES WITH THE NEEDLE GETTING STUCK WHILE BEING RETRACTED. ANOTHER IV LANDED ON MY DESK THAT HAS NOT BEEN PLACED IN A PATIENT, AS THE NURSE CHECKED THE NEEDLE TO ENSURE IT WOULD WITHDRAW AND FOUND IT TO BE ROUGH. IT IS HARDER TO PULL THIS NEEDLE BACK AND MAKES A SCRAPING NOISE. LOT #9233236.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286760 BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383536 9233236 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other