BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7334975 · Received March 13, 2018

    Report

    Report Number
    1710034-2018-00118
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    February 5, 2018
    Report Date
    April 9, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION RESULTS: ONE SAMPLE UNIT WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, THE PACKAGING WAS OBSERVED TO BE PARTIALLY OPENED. THE PRODUCT REQUIRES A MINIMUM OF A 1/8" SEAL WIDTH; THIS CHARACTERISTIC WAS OBSERVED ON THE RETURNED SAMPLE. THE SAMPLE WAS ANALYZED UNDER UV LIGHT, AS THE ADHESIVE USED IS UV FLUORESCENT. THE ANALYSIS REVEALED AN ADEQUATE AMOUNT OF ADHESIVE. DEVICE/BATCH HISTORY RECORD REVIEW FINDINGS: DHR REVIEW WAS PERFORMED ON THE LOT NUMBER 7031941. THE LOT NUMBER WAS PACKAGED ON PACKAGING LINE 11 FROM FEBRUARY 11, 2017 THRU FEBRUARY 14, 2017. PER REVIEW OF THE DHR¿S IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND IN PROCESS SAMPLING PLANS. SET-UP AND IN-PROCESS SAMPLES (INCLUDED BUT NOT LIMITED) BLISTER THICKNESS, BAD SEAL/CUT/HOLES, SEAL TRANSFER WIDTH AND PACKAGE LEAK TEST WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT CURRENT RISK IS ACCEPTABLE. OCCURRENCE AND SEVERITY RANKINGS HAVE NOT CHANGED. OBSERVATIONS AND TESTING: RECEIVED ONE UNUSED IAG 22GA UNIT IN PARTIALLY OPENED PACKAGE FROM THE LOT NUMBER; 7031941. VISUAL/MICROSCOPIC EXAMINATION: THE PACKAGE WAS OPENED AT THE BOTTOM OF THE BLISTER PACK. THE ANALYSIS OF TOP WEB ADHESIVE: THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. THIS CHARACTERISTIC WAS MET. IN ADDITION, THE PAPER TOP WEB OF THE RETURNED UNIT WAS ANALYZED UNDER UV LIGHT. THE GLUE USED TO SEAL THE TOP AND BOTTOM WEBS IS UV FLUORESCENT. THE ANALYSIS REVEALED AN ADEQUATE OF TOP WEB ADHESIVE. THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND TOP WEB GLUE. BOTH VARIABLES WERE LOOKED AT DURING THE INVESTIGATION. THE RETURNED UNIT PROVIDED FOR EVALUATION FOR THIS INCIDENT MET THE MANUFACTURING SPECIFICATION REQUIREMENTS REGARDING PACKAGE SEAL INTEGRITY. EVEN THOUGH THE PACKAGE CAME PARTIALLY OPENED, ALL THE PROCESSES CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH ARE: SEAL TRANSFER AND TOP WEB GLUE, MEASURED WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. CAPA 48637 HAS BEEN OPENED IN RESPONSE TO SIMILAR COMPLAINTS FOR THE DEVICE AND AN ACTION PLAN WILL COVER THE IMPLEMENTATION OF AN ENTIRE NEW TOP WEB AS WELL AS AN INCREASED PLAN OF DETECTION AND INDIVIDUAL LOTS WILL BE CONTAINED AS NEEDED PER THE QN PROCESS OR COMPLAINT INVESTIGATION PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING OF A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS NOT SEALED PROPERLY. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179802 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7031941 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other