BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7035538 · Received November 15, 2017

    Report

    Report Number
    1710034-2017-00325
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 21, 2017
    Report Date
    December 13, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835195
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: MDR LEVEL A INVESTIGATION. DHR REVIEW - BOTH BATCHES: 7045667- THE LOT NUMBER WAS BUILT ON NFA #1, FROM FEBRUARY 16, 2017 THROUGH FEBRUARY 18, 2017. PER SPECIFICATIONS IN (B)(4) IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGED SAMPLED AND 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. 7153575- THE LOT NUMBER WAS BUILT ON NFA #1, FROM JUNE 8, 2017 THROUGH JUNE 10, 2017 PER SPECIFICATIONS IN (B)(4) IT AS CONCLUDED THAT ALL REQUIRED CHALLENGED SAMPLED AND TESTING WAS PERFORMED, IN ACCORDANCE WITH THE SET-UP AND 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. - QN REVIEW - BOTH BATCHES - WITH THE REVIEW OF THE DHR, NO QNS WERE IDENTIFIED RELATING TO THE DEFECT IN THE COMPLAINT. EURA REVIEW - THIS DEFECT CAN BE CAUSED BY ALIGNMENT AND DAMAGE. THE RISK IS CONSIDERED ACCEPTABLE GIVEN THE ASSESSMENT OF THE OCCURRENCE AND SEVERITY OF POTENTIAL EFFECTS OF FAILURE DUE TO "TUBING DETACH / DAMAGE" VISUAL ANALYSIS- OBSERVATION AND TESTING: RECEIVED ONE USED NEXIVA 18GA UNIT AND TWO PACKAGES LABELS BOTH FROM CATALOG NUMBER 383519, ONE FROM LOT 7045667 AND ONE FROM LOT 7153575. VISUAL/MICROSCOPIC EXAMINATION: THE UNIT HAD BODILY FLUIDS/MEDS FROM CATHETER TUBING THROUGH THE EXTENSION TUBING OBSERVED A KINKED/FLAT AREA IN THE EXTENSION TUBING LOCATED AT THE CLEAR PORT OF THE WINGED ADAPTER. THE EXTENSION TUBING WAS NOT SEATED PROPERLY INSIDE OF THE LEUR ADAPTOR. WATER/AIR LEAK TEST: USING A LAB SUPPLIED ISO LEUR SLIP CONNECTION TEST FITTING, PERFORMED A WATER/AIR LEAK TEST. LEAKAGE WAS OBSERVED COMING FROM THE KINKED AREA OF THE EXTENSION TUBING. SAMPLE ANALYSIS - THE EXTENSION TUBING WAS NOT PROPERLY INSERTED INTO THE CATHETER ADAPTER. INVESTIGATION CONCLUSION: THE DEFECT WAS CONFIRMED THROUGH THE INVESTIGATION. THE EXTENSION TUBING WAS NOT PROPERLY INSERTED INTO THE CATHETER ADAPTER. INVESTIGATION SAMPLES MEET MANUFACTURING SPECIFICATION? NO, THE RETURNED UNIT PROVIDED FOR EVALUATION DISPLAYED KINKED/FLAT EXTENSION AT THE CLEAR PORT OF THE WINGED ADAPTER WHICH DID LEAK. CONCLUSION: THE DEFECTS LEAKAGE AND BLOOD EXCESS/SPLASH/EXPOSURE: AS STATED AS THE REPORTED CODED WAS CONFIRMED WITH THE RETURNED UNIT. CONFIRMED THE EXTENSION TUBING WAS KINKED AND NOT PROPERLY SEATED INSIDE THE PORT OF THE WINGED ADAPTER, LEAVING AN OPENED PATHWAY FOR LEAKAGE. THE PORTION OF TUBING THAT DID NOT INSERT INTO THE LEUR ADAPTER HAS THE ADAPTER HAS THE APPEARANCE OF FOREIGN. ROOT CAUSE DESCRIPTION: THE CAUSE FOR THE DEFECT WAS IMPROPER INSERTION OF THE TUBING INTO THE CATHETER ADAPTER. A 100% INSPECTION SYSTEM IS UTILIZED TO CATCH THESE TYPES OF DEFECTS. IT COULD NOT BE DETERMINED HOW THE VISION SYSTEM DID NOT IDENTIFY THIS DEFECT. RATIONALE: THE OCCURRENCE AND SEVERITY OF THIS DEFECT AS REPORTED DO NOT EXCEED THE EVALUATION OF THE RISK IDENTIFIED IN THE EURA. OTHER ACTION TAKEN: PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTE INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND/OR PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED , DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN. THE MANUFACTURING DEPARTMENT WAS NOTIFIED OF THIS INCIDENT FINDINGS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7045667, MEDICAL DEVICE EXPIRATION DATE: 01/31/2020, DEVICE MANUFACTURE DATE: 02/14/2017, MEDICAL DEVICE LOT #: 7153575, MEDICAL DEVICE EXPIRATION DATE: 05/31/2020, DEVICE MANUFACTURE DATE: 06/02/2017. 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 ) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD AN OPEN ENDED EXTRA PIECE OF TUBING WHERE THE PRODUCT BIFURCATES CAUSING LEAKAGE OF BLOOD. FOUND DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814699 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10. 00382903835195

    Patients

    Seq Age Sex Outcome Treatment
    1 Other