BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7709462 · Received July 22, 2018

    Report

    Report Number
    1710034-2018-00430
    Event Type
    Malfunction
    Date Received
    July 22, 2018
    Date of Event
    July 2, 2018
    Report Date
    August 28, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814672
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE RETURNED UNIT AND PHOTOGRAPH PROVIDED BY YOUR FACILITY. BD RECEIVED FOUR INSYTE AUTOGUARD 14GA PACKAGES FROM LOT NUMBER: 5232532. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE SET-UP AND IN PROCESS SAMPLES (INCLUDED BUT NOT LIMITED) BLISTER THICKNESS, BAD SEAL/CUT/HOLES, SEAL TRANSFER WIDTH AND PACKAGE LEAK TESTS WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE MANUFACTURING PACKAGING PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. THE ANALYSIS OF THE TOP WEB ADHESIVE WHERE THE PRODUCT CHARACTERISTICS REQUIRE A SPECIFIC SEAL TRANSFER WAS MET PER SPECIFICATIONS. IN ADDITION, THE PAPER TOP WEB OF THE RETURNED UNITS WERE ANALYZED UNDER A UV LIGHT. THE GLUE USED TO SEAL THE TOP AND BOTTOM WEBS IS UV FLUORESCENT. THIS ANALYSIS REVEALED AN ADEQUATE AMOUNT 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 UNITS PROVIDED FOR EVALUATION FOR THIS INCIDENT MET THE MANUFACTURING SPECIFICATION REQUIREMENTS. IN CONCLUSION, WHERE THE PACKAGES WERE FOUND PARTIALLY OPENED, THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH (SEAL TRANSFER AND TOP WEB GLUE), MEASURED WITHIN SPECIFICATION. INVESTIGATION CONCLUSION: THE DEFECT STATED IN THE DESCRIPTION OF THE COMPLAINT WAS CONFIRMED WITH THE RETURNED UNIT. EVEN THOUGH THE PACKAGE WAS RECEIVED PARTIALLY OPENED, ALL THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL WERE OBSERVED TO BE WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. UNABLE TO DETERMINE A ROOT CAUSE. DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD STERILE BREACH. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5232532, MEDICAL DEVICE EXPIRATION DATE: 2018-07-31, DEVICE MANUFACTURE DATE: 2015-08-20. MEDICAL DEVICE LOT #: 6215627, MEDICAL DEVICE EXPIRATION DATE: 2019-07-31, DEVICE MANUFACTURE DATE: 2016-08-03. MEDICAL DEVICE LOT #: 6308948, MEDICAL DEVICE EXPIRATION DATE: 2019-10-31, DEVICE MANUFACTURE DATE: 2016-11-08. MEDICAL DEVICE LOT #: 6042643, MEDICAL DEVICE EXPIRATION DATE: 2019-01-31, DEVICE MANUFACTURE DATE: 2016-02-12. (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 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD STERILE BREACH. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551359 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10. 30382903814672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other