BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8030225 · Received November 1, 2018

    Report

    Report Number
    1710034-2018-00772
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 15, 2018
    Report Date
    December 14, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835370
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED ONE USED 20GA BD NEXIVA IV CLOSED IV CATHETER SYSTEM D/L, WHICH CONSISTED OF THE CATHETER/ADAPTER AND EXTENSION LINE ASSEMBLIES. UNIT RECEIVED IN 2 PORTIONS. TWO PHOTOS WERE PROVIDED FOR OBSERVATION OF THIS INCIDENT WHICH REVEALED A 20GA NEXIVA IV CATHETER DUAL/LUMEN IN THE SAME CONDITION AS THAT OF THE RETURNED UNIT. ALTHOUGH THE LOT NUMBER WAS REPORTED AS UNKNOWN, 5 LOT NUMBERS WERE SUBMITTED BY THE CUSTOMER AS PRODUCT PRESENT ON THEIR SHELVES OF THE SAME PRODUCT CODE (383537); DHR REVIEWS WERE CONDUCTED ON THESE 5 LOTS FOR THIS INVESTIGATION WHICH DISCLOSED THE FOLLOWING: LOT 8012777; WAS BUILT AND PACKAGED ON NFA LINE 1 ON 14JAN2018 THROUGH 19JAN2018 FOR THE QUANTITY OF 228,490EA. 1 NON-RELATED TD WAS IN PLACE DURING THE PRODUCTION OF THIS LOT; (TD2017-81 ¿TEMPORARY CONTROLS AROUND SPLICE TAPE DETECTION¿) ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. LOT 8054970; WAS BUILT AND PACKAGED ON NFA LINE 1 ON 23FEB2018 THROUGH 26FEB2018 FOR THE QUANTITY OF 134,410EA. THERE WERE FOUR QNS: THREE IP QNS (200735457-DAMAGE AT CATHETER ADAPTER), (200735458-PACKAGE REGISTRATION OFF) AND (200735584-DIFFICULT RETRACTION) INITIATED DURING THIS BUILD AND A COPY OF 1 IP QN (200735584-L/N 8067516) WITH THIS LOT REFERENCED AS A POTENTIALLY AFFECTED LOT. ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. LOT 8080624; WAS BUILT AND PACKAGED ON NFA LINE 1 ON 22MAR2018 THROUGH 25MAR2018 FOR THE QUANTITY OF 146,730EA. 3 NON-RELATED TD¿S WERE IN PLACE DURING PRODUCTION (TD2018-16 VERIFICATION OF REGISTRATION-PKG., TD2018-20 100% VISUAL FOR HOT PEEL-PKG. AND TD2018-21 EXCEPTION (NO QN) FOR DAMAGE TO BOTTOM OF CANISTER.) ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. LOT 8107726; REVIEW WAS PREVIOUSLY CONDUCTED FOR INVESTIGATION (PR 591427-629123 CR) WHICH DISCLOSED THE FOLLOWING:LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE #1 FROM 18APRIL2018 THRU 21APRIL2018. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED FOUR QNS 20074536, 200745350, 200754184 AND 200745417 WERE INITIATED DURING BUILD OF THIS LOT FOR EXTENSION TUBING BOND STRENGTH OOS THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. NOTE THAT AT THE TIME OF CONDUCTING THIS INCIDENT INVESTIGATION, THE DHR AND THREE OF THE RELATED QNS WERE STILL OPENED. LOT 8138602; REVIEW WAS PREVIOUSLY CONDUCTED FOR INVESTIGATION (PR 557403-587934 CR) WHICH DISCLOSED THE FOLLOWING: THE LOT NUMBER WAS BUILT/PACKAGE ON NFA LINE 1 FROM MAY 21, 2018 THRU MAY 24, 2018 FOR THE AMOUNT OF 120,970. 3 NON-RELATED TD¿S WERE IN PLACE DURING PRODUCTION (TD2018-16 VERIFICATION OF REGISTRATION-PKG. TD2018-23 ADHESIVE DEEP CLEANING AND TD2018-20 100% VISUAL FOR HOT PEEL-PKG.) ALL CHALLENGES, SET UP AND IN-PROCESS SAMPLES WERE PERFORMED ACCORDING TO THE QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. SAP (QN) DATABASE REVIEW; WAS CONDUCTED FOR THIS INVESTIGATION, WHICH DISCLOSED THE FOLLOWING: THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE REPORTED DEFECT ASSOCIATED WITH LOT NUMBERS 8080624 AND 8138602, AS NO QNS WERE INITIATED DURING THESE LOTS. THERE WAS ONE NON-RELATED IP QN (20072843 ¿DAMAGED ADAPTERS) INITIATED FOR LOT 8012777, WHICH WAS NOT RELEVANT TO THE REPORTED DEFECT. THERE WERE THREE IP QNS (200735457-DAMAGE AT CATHETER ADAPTER), (200735458-PACKAGE REGISTRATION OFF) AND (200735584-DIFFICULT RETRACTION) INITIATED FOR LOT 8054970, WHICH WERE NOT RELEVANT TO THE REPORTED DEFECT. VISUAL/MICROSCOPIC EVALUATION: UNIT: THE EXTENSION TUBING WAS SEPARATED FROM WITHIN THE CLEAR PORT OF THE CATHETER/ADAPTER (STABILIZATION PLATFORM).THERE WERE NO VISIBLE TRACES OF ADHESIVE OBSERVED ON THE EXTENSION TUBING OR WITHIN THE CLEAR PORT OF THE CATHETER/ADAPTER (STABILIZATION PLATFORM). PHOTOS: THE PHOTOS REVEALED SEPARATION OF THE EXTENSION TUBING FROM WITHIN THE CLEAR PORT OF THE CATHETER/ADAPTER (STABILIZATION PLATFORM). PROBABLE ROOT CAUSE FOR THIS INCIDENT IS MANUFACTURING. THE DEFECT IDENTIFIED IN THIS INCIDENT WAS CREATED AT THE ZONE 8 ADHESIVE DISPENSE STATION AFTER THE STATION REDESIGN. IF AIR GOT IN THE LINES THAT FED ADHESIVE TO THE ADHESIVE DISPENSE GRIPPERS, A SHORT SHOT OF ADHESIVE WOULD BE DISPENSED ONTO THE TUBE. A NEW STATION DESIGN WAS INSTALLED ON NFA1 ZONE 8 IN APRIL 2018 (PROTOCOL 18449) THAT THE EXTENSION TUBE ADHESIVE DISPENSE STATIONS ARE PURGED ON A REGULAR BASIS AND CURRENT PROCESS CONTROLS INCLUDE ROUTINE LEAK TEST AND EXT. PULL TEST WELL AS A 100% ONLINE FLOW TESTER IN ZONE 8. THE ANALYSIS OF PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. WITH LIMITED SEVERITY AND OCCASIONAL OCCURRENCE, THE RISK TO THE END USER IS ACCEPTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXTENSION LINES ON A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM FELL OFF. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(6). 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 EXTENSION LINES ON A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM FELL OFF. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868299 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 30382903835370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other