BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT

    MDR report key: 7110754 · Received December 12, 2017

    Report

    Report Number
    1710034-2017-00455
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 20, 2017
    Report Date
    February 26, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: INVESTIGATION LEVEL A: DHR REVIEW - YES, REQUIRED FOR MDR; DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 7242997 WAS BUILT ON NFA #1, FROM AUGUST 31, 2017 THRU SEPTEMBER 8, 2017. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. INVESTIGATION CONCLUSION: THE CUSTOMER'S EXPERIENCE COULD NOT BE CONFIRMED OR REPRODUCED BY THE REPRESENTATIVE SAMPLES RECEIVED. VISUAL/MICROSCOPIC EXAMINATION DID NOT FIND ANY DAMAGE TO THE CATHETER OR EXTENSION TUBING OF THE RECEIVED UNITS. TIP QUALITY ON ALL UNITS WAS GRADED AS ACCEPTABLE. ALL UNITS PASSED THE AIR/WATER LEAK TEST. RM5796 REV13(L) NEXIVA P-EURA HAS IDENTIFIED AREAS OF THE PRODUCTION PROCESS THAT CAN CAUSE DAMAGE TO THE CATHETER OR EXTENSION TUBING. BASED ON THE CUSTOMER'S VERBATIM DESCRIPTION, THE EFFECTS OF THE DEFECT WERE CLINICIAN DISSATISFACTION WITH NEGLIGIBLE SEVERITY OF S1 AND POSSIBLE MULTIPLE PIV INSERTIONS REQUIRED WITH LIMITED SEVERITY OF S2. OCCURRENCE OF THIS DEFECT IS LOW FOR THIS BATCH. WITH LIMITED SEVERITY AND LOW OCCURRENCE, THE RISK TO THE END USER IS ACCEPTABLE. ROOT CAUSE: THE DEFECTIVE UNIT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEFINITE ROOT CAUSE WAS NOT ESTABLISHED; THERE WAS NO DEFINITE PHYSICAL OR MECHANICAL EVIDENCE THAT CONFIRMED AND SUPPORTED MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT OBSERVED IN THIS INCIDENT. ROOT CAUSE IS INDETERMINATE. RATIONALE: THE DEFECTIVE UNIT WAS NOT RETURNED FOR EVALUATION AND TESTING. ROOT CAUSE IS INDETERMINATE. SEVERITY IS LIMITED AND OCCURRENCE LOW.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER: CHANGED FROM 11/20/2017 TO 11/21/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE AND AFTER INSERTION OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT INTO THE PATIENT¿S ARM THE NURSE ATTEMPTED TO RETRACT THE NEEDLE FROM THE CATHETER TUBING AND NOTICED THE CATHETER WAS BRITTLE AND CRACKED UPON RETRACTION. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890113 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 Other