BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7334979 · Received March 13, 2018

    Report

    Report Number
    1710034-2018-00116
    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

    INVESTIGATION RESULTS: SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, THE PACKAGE WAS OBSERVED TO BE PARTIALLY OPEN. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE OBSERVED DEFECT. ALTHOUGH THE PACKAGE WAS OBSERVED TO BE PARTIALLY OPENED, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FROM THE PROVIDED PICTURES; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. DEVICE/BATCH HISTORY RECORD REVIEW FINDINGS: DHR REVIEW WAS PERFORMED ON THE LOT NUMBER 6260965. THE LOT NUMBER WAS PACKAGED ON PACKAGING LINE 11 FROM SEPTEMBER 22, 2016 THRU SEPTEMBER 28, 2016. 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; 6260965. VISUAL/MICROSCOPIC EXAMINATION: THE PACKAGE WAS OPENED AT THE TOP OF THE BLISTER PACK. THE ANALYSIS OF TOP WEB ADHESIVE: THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. PER OBSERVATION OF THE PHOTOS PROVIDED THIS CHARACTERISTIC WAS MET. IN ADDITION, THE BOTTOM WEB IN THE PHOTOS REVEALED EVIDENCE OF ADEQUATE TRANSFER (ADHESIVE) FROM THE PAPER TOP WEB AT THE OPEN SEALS AND PARTIALLY OPEN SEALS OF THE PACKAGES (BLISTER PACKS). THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND PAPER TOP WEB GLUE. BOTH VARIABLES WERE INCLUDED IN THE INVESTIGATION. THE RETURNED UNIT PROVIDED FOR EVALUATION FOR THIS INCIDENT MET THE MANUFACTURING SPECIFICATION REQUIREMENTS REGARDING PACKAGE SEAL INTEGRITY. CONCLUSIONS: THE DEFECT OF PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE AS STATED IN EVENT DESCRIPTION WAS CONFIRMED WITH THE RETURNED UNITS. NO ANOMALIES WERE FOUND AND ALL THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH WERE OBSERVED TO BE WITHIN SPECIFICATION. THE UNITS WERE ACCEPTABLE PER SPECIFICATION REQUIREMENTS. ALTHOUGH THE PACKAGES WERE OBSERVED TO BE PARTIALLY OPENED, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. CAPA 48637 HAS BEEN OPENED TO INVESTIGATE THE PACKAGE OPEN SEAL DEFECTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (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
    179800 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6260965 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other