BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7765393 · Received August 8, 2018

    Report

    Report Number
    1710034-2018-00509
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    July 19, 2018
    Report Date
    September 17, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835196
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: RECEIVED ON NEXIVA CATHETER-ADAPTER EXTENSION SET ALONG WITH 2 EMPTY-OPEN PACKAGES FROM LOTS 7153575 AND 8045649 RESPECTIVELY. THE NEEDLE ASSEMBLY WAS NOT RETURNED FOR EVALUATION. DHR REVIEW: 7153575: THE LOT NUMBER WAS BUILT ON NFA #1, FROM JUNE 8, 2017 THROUGH JUNE 10, 2017 8045649: THE LOT NUMBER WAS BUILT ON NFA #1, FROM FEB 16, 2018 THROUGH FEB 20,2018 ALL CHALLENGES, SET-UP AND IN-PROCESS SAMPLES WERE PERFORMED PER QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. VISUAL/MICROSCOPIC EVALUATION: THE UNIT HAD TRACES OF PATIENT RESIDUE VISIBLE THROUGHOUT ITS COMPONENTS. PROMINENT TRACES OF BLOOD WERE PRESENT AROUND THE EDGE OF THE SEPTUM AND THE CANISTER. THE SEPTUM-CANISTER ASSEMBLY DISPLAYED IT HAD BEEN IMPROPERLY ASSEMBLED. UPON DISSECTION IT WAS DISCOVERED MORE DAMAGE WAS PRESENT ON THE CANISTER AND THE SEPTUM (FOLDS, CREASES, TEARS) WATER/AIR LEAK TEST: WATER/AIR LEAK TEST WAS PERFORMED BY CONNECTING THE END OF THE LAB SUPPLIED MALE SLIP LUER TEST FITTING TO THE ADAPTER. NO LEAKAGE WAS OBSERVED (PRESUMABLY BLOCKAGE CAUSED FROM DRY BLOOD) END USER RISK ANALYSIS (EURA) REVIEW WAS ANALYZED AND CAUSES OF ¿SEPTUM LEAK¿ ARE MISALIGNMENT OF GRIPPERS DURING ASSEMBLY OF THE CANNULA INTO THE SEPTUM AND INSUFFICIENT LUBRICATION DURING ASSEMBLY OF THE SEPTUM ASSEMBLY INTO THE CATHETER ADAPTER. NEITHER OF THESE FAILURE MODES WERE ABLE TO BE CONFIRMED THROUGH THE INVESTIGATION. PROBABLE ROOT CAUSE COULD BE RELATED TO MANUFACTURING. A DEFINITIVE CAUSE THAT TRIGGERED THE DAMAGE OBSERVED ON THE SEPTUM ASSEMBLY COULD NOT BE DETERMINED. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. 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. MANUFACTURING REPRESENTATIVES WERE MADE AWARE OF THE DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SEAL OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WAS DEFECTIVE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7153575. MEDICAL DEVICE EXPIRATION DATE: 2020-05-31. DEVICE MANUFACTURE DATE: 2017-06-02. MEDICAL DEVICE LOT #: 8045649. MEDICAL DEVICE EXPIRATION DATE: 2021-01-31. DEVICE MANUFACTURE DATE: 2018-02-14. 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 THE SEAL OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WAS DEFECTIVE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606298 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE SECTION H.10. 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other