BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1.00 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 6835707 · Received August 31, 2017

    Report

    Report Number
    1710034-2017-00170
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 15, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K102520
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION: DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 6113858 ¿ THE LOT NUMBER WAS BUILT ON (B)(4), FROM APRIL 22, 2016 THRU APRIL 28, 2016. PER SPECIFICATIONS IN QCNVA-(B)(4) IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES 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 / SAP DATABASE REVIEW: YES. REASON: A REVIEW OF THE QN/SAP DATABASE SHOWS THAT NO QUALITY NOTIFICATIONS RELATED TO THIS DEFECT WERE ISSUED ON THIS BATCH. EURA REVIEW (END USER RISK ANALYSIS): YES. REASON: THE REVIEW OF THE EURA IS REQUIRED IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE (MDR). FINDINGS: (B)(4) WAS REVIEWED TO DETERMINE THE RISK TO CUSTOMER. THE RISK IS CONSIDERED ACCEPTABLE GIVEN A LIMITED SEVERITY (S2) AND ONLY REMOTE OCCURRENCES (=10.0 IPM). VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED (B)(4) UNUSED NEXIVA 22GA UNITS IN SEALED PACKAGES FROM THE LOT NUMBER 6113858. THE UNITS WERE RECEIVED IN ONE SHIPPER WHICH HAD (B)(4) DISPENSERS WITH (B)(4) UNITS EACH. VISUAL/MICROSCOPIC EXAMINATION: NO BENDS, CUTS, HOLES, KINKS, SPLITS, OR WRINKLES WERE OBSERVED IN THE CATHETER OR EXTENSION TUBING. THE WEDGE, PRIMARY SEPTUM AND SECONDARY SEPTUM WERE PROPERLY INSTALLED. OBSERVED THERE WAS NO DAMAGE TO THE WEDGE OR HUB OF THE WINGED ADAPTER THE EXTENSION TUBING WAS INSERTED PROPERLY INTO THE WINGED ADAPTER AND Y-ADAPTER PORTS. OBSERVED THERE WERE NO CRACKS OR DAMAGE TO THE WINGED ADAPTER AND Y-ADAPTER OBSERVED THE VENT PLUG WAS INSERTED INTO THE LUER OF THE Y-ADAPTER FLASHBACK TEST: FLASHBACK TESTING WAS PERFORMED ON THE UNIT. UPON INSERTION OF THE NEEDLE INTO THE ARTIFICIAL VEIN; THE INITIAL FLASHBACK VISUALIZATION COULD BE SEEN VERY QUICKLY IN THE CHAMBER OF THE CATHETER/ADAPTERS. THE NEEDLE WAS THEN DISENGAGED FROM THE CATHETER TUBING WHILE STILL IN THE ARTIFICIAL VEIN; AT THIS POINT THE RED COLOR/WATER MIX FLOWED THROUGH THE CATHETER AND EXTENSION TUBING UNTIL IT REACHED THE FLOW CONTROL PLUG. NO LEAKAGE WAS OBSERVED ON ANY OF THE AREAS OF THE UNIT RECEIVED FOR EVALUATION WATER/AIR LEAK TEST: USING A LAB SUPPLIED ISO LUER SLIP CONNECTION TEST FITTING, PERFORMED A WATER/AIR LEAK TEST, LEAKAGE WAS NOT OBSERVED IN ANY AREA OF THE NEXIVA UNITS. TEST DESCRIPTION METHOD: NO RESULTS. VISUAL/MICROSCOPIC: N/A. SEE OBSERVATIONS AND TESTING . FLASHBACK QCGE-(B)(4). SEE OBSERVATIONS AND TESTING. WATER/AIR LEAK TEST (B)(4). SEE OBSERVATIONS AND TESTING. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES, THE RETURNED UNITS THAT WERE PROVIDED FOR EVALUATION FOR THIS INCIDENT MET AND PERFORMED TO MANUFACTURING SPECIFICATION. CONCLUSIONS: THE DEFECT OF LEAKAGE, AS STATED IN THE SUBJECT OF THE PIR, WAS NOT CONFIRMED WITH THE RETURNED UNITS. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? NO; THE CUSTOMER EXPERIENCED WAS NOT CONFIRMED BASED ON THE EVALUATION AND TESTING THAT WAS PERFORMED ON THE RETURNED UNITS. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO; REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE WAS NOT ACHIEVED WITH THE TESTING PERFORMED ON THE RETURNED UNITS. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. COMMENT: THERE WAS NO DEFINITE PHYSICAL OR MECHANICAL EVIDENCE THAT CONFIRMED AND SUPPORTED MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT OBSERVED IN THIS INCIDENT. CORRECTIONS AND CAPA : CORRECTIVE ACTION PROJECT / CAPA (#): A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. SEVERITY IS LIMITED AND OCCURRENCE LOW. 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. OTHER ACTION TAKEN: PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE 22 G X 1.00 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THERE WAS LEAKING. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614657 22 G X 1.00 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVENOUS CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6113858

    Patients

    Seq Age Sex Outcome Treatment
    1 Other