BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT

    MDR report key: 7578929 · Received June 7, 2018

    Report

    Report Number
    1710034-2018-00263
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    May 17, 2018
    Report Date
    August 16, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW A TOTAL OF 416,650 WERE MANUFACTURED ON NEXIVA LINE 1 STARTING ON 2FEB18 THROUGH 10FEB18. ALL CHALLENGES, SET-UP AND IN PROCESS SAMPLES INCLUDING (BUT NOT LIMITED TO) MACHINE CAUSED DAMAGE AND AIR-WATER LEAK TEST PASSED PER SPECIFICATION. SAP-QN DATABASE REVIEW FOUND 4 NON-RELATED QN¿S ¿ 200732637 (DAMAGED SEPTUM). ¿ 200739252 (WRONG TIPPING DIE). ¿ 200731792 (RUNNING UNDER RISK-NIKON DOWN) .¿ 200315587 (INCOMPLETE SEAL) . THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. OBSERVATIONS AND TESTING: RECEIVED ONE 20GA USED NEXIVA UNIT CONSISTING ON A CATHETER-ADAPTER EXTENSION SET AND A PARTIALLY DISENGAGED NEEDLE-GRIP ASSEMBLY INSIDE OF AN OPEN PACKAGE FROM LOT NUMBER 8031857. VISUAL/MICROSCOPIC EXAMINATION: ¿ THE UNIT HAD TRACES OF PATIENT RESIDUE (BLOOD) THROUGHOUT THE COMPONENTS. ¿ OBSERVED THE NEEDLE TIP HAD SPEARED THROUGH THE CATHETER TUBING, LEAVING A V SHAPED CUT ¿ WATER/AIR LEAK TEST WAS PERFORMED BY CONNECTING THE END OF THE LAB SUPPLIED MALE SLIP LUER TEST FITTING TO THE ADAPTER. LEAKAGE OCCURRED FROM THE AREA WHERE THE CANNULA SPEARED THROUGH THE TUBING. THE UNIT LEAKED THROUGH THE CUT ON THE CATHETER TUBING, THE ¿V SHAPE¿ CUT OBSERVED IN THE CATHETER TUBING IS A CHARACTERISTIC OF DAMAGE LIKELY CAUSED BY RE-INSERTION/RE-CANNULATION OF THE CANNULA INTO THE CATHETER. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A RN INSERTED A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/DUAL PORT INTO A PATIENT¿S VEIN AND DURING RETRACTION, THE NEEDLE PUNCTURED THE TUBING AND SEVERED THE HUB CAUSING BLOOD TO LEAK OUT OF TUBE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    FDA NOTIFIED YES: THE INITIAL REPORTER ALSO NOTIFIED THE FDA IN (B)(6) 2018 VIA MEDWATCH #(B)(4). 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 A RN INSERTED A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/DUAL PORT INTO A PATIENT¿S VEIN AND DURING RETRACTION, THE NEEDLE PUNCTURED THE TUBING AND SEVERED THE HUB CAUSING BLOOD TO LEAK OUT OF TUBE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423118 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8031857 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other