BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1.25 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 6870365 · Received September 15, 2017

    Report

    Report Number
    1710034-2017-00187
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    July 20, 2017
    Report Date
    September 29, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DEVICE/BATCH HISTORY RECORD REVIEW: YES. REASON: DHR¿S ARE AVAILABLE FOR REVIEWS AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE (MDR). FINDINGS: AS THIS COMPLAINT WAS A MDR; DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 7040645. 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. FINDINGS: THE QN REVIEWED REVEALED NO RELATED REJECT ACTIVITY FOR THE SUB-ASSEMBLY LOT NUMBER ASSOCIATED WITH THIS INCIDENT. PEURA REVIEW: YES. REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: (B)(4) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT LEAKAGE THROUGH THE SEPTUM WAS ASSESSED AND CONSIDERED ACCEPTABLE AT A HIGH OCCURRENCE GIVEN A LIMITED SEVERITY. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED ONE USED NEXIVA 20GA UNIT IN AN OPENED PACKAGE FROM THE LOT NUMBER 7040645. VISUAL/MICROSCOPIC EXAMINATION: OBSERVED BODILY FLUIDS/MEDS THROUGHOUT THE UNIT. THE WEDGE, PRIMARY SEPTUM AND SECONDARY SEPTUM WERE PROPERLY INSTALLED. PERFORMED A WATER/AIR LEAK TEST ON THE UNIT; NO LEAKAGE WAS OBSERVED IN ANY AREAS OF THE NEXIVA UNIT. THE UNIT WAS DISSECTED AND THE SEPTUM WAS MICROSCOPICALLY OBSERVED; OBSERVED THERE WAS CORING (HOLE) OF THE PRIMARY SEPTUM THE SEPTUM SLIT CUT WAS PRESENT. TEST DESCRIPTION METHOD NO RESULTS: VISUAL/MICROSCOPIC N/A SEE OBSERVATIONS AND TESTING. WATER/AIR LEAK TEST (B)(4) SEE OBSERVATIONS AND TESTING. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO, THE RETURNED UNIT THAT WAS PROVIDED FOR EVALUATION REVEALED CORING OF THE PRIMARY SEPTUM. CONCLUSIONS: THE DEFECT OF LEAKING AT THE SEPTUM WITH NEXIVA, AS STATED IN THE SUBJECT OF THE PIR WAS NOT CONFIRMED WITH THE RETURNED UNIT. HOWEVER, THE UNIT WAS DISSECTED AND OBSERVED THERE WAS CORING OF THE PRIMARY SEPTUM WHICH IS A KNOWN DEFECT FOR ALLOWING LEAKING AT THE SEPTUM WITH NEXIVA IN THE CLINICAL SETTING. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? YES; ALTHOUGH THE CUSTOMER EXPERIENCED WAS NOT CONFIRMED, THE DISSECTION OF THE PRIMARY SEPTUM FOUND THAT SEPTUM WAS CORED WHICH COULD RESULT IN LEAKAGE. 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 UNIT. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: MANUFACTURING. COMMENT: THE DAMAGE CAN OCCUR DURING ASSEMBLY WHEN THE CANNULA BACKEND IS INSERTED THROUGH A SLIT IN THE SEPTUM. HOWEVER, DURING THE INVESTIGATION, NOTHING ABOUT THE PROCESS WAS IDENTIFIED AS A ROOT CAUSE. PROJECT (B)(4) REDESIGNED THE CANNULA AND SEPTUM WHICH RESULTED IN A CHANGE TO THE INSERTION PROCESS. THE CHANGE IN THE PROCESS IS EXPECTED TO REDUCE THE OCCURRENCE OF THIS DEFECT. CORRECTIONS AND CAPA: CORRECTIVE ACTION PROJECT / CAPA (#): 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. 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.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UDI #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE LEAKAGE FOUND ON A 20 G X 1.25 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM AT THE STOP VALVE DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648530 20 G X 1.25 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7040645

    Patients

    Seq Age Sex Outcome Treatment
    1 Other