BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8135236 · Received December 5, 2018

    Report

    Report Number
    1710034-2018-00869
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 14, 2018
    Report Date
    February 27, 2019
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR REVIEW WAS CONDUCTED FOR THIS INVESTIGATION WHICH DISCLOSED THE FOLLOWING: LOT: 8192723; WAS BUILT AND PACKAGED ON AFA LINE 12 ON 13JUL2018 THROUGH 18JUL2018 FOR A TOTAL QUANTITY OF 461,810EA. ALL OTHER CHALLENGE, SET-UP AND IN PROCESS SAMPLES WERE PERFORMED ACCORDING TO THE QUALITY SAMPLING PLANS. ONE POTENTIALLY RELATED IP QN (B)(4) ¿EXCESS GEL¿)) WAS INITIATED DURING THE BUILD OF THIS LOT. RECEIVED ONE 22GA BD INSYTE AUTOGUARD BLOOD CONTROL IV CATHETER UNIT WITHIN AN OPENED PACKAGE FROM LOT: 8192723. ALL COMPONENTS WERE PRESENT WITH THE NEEDLE/HUB ASSEMBLY FULLY RETRACTED WITHIN THE BARREL. A PORTION OF THE TOP WEB (LID) OF THE PACKAGE WAS TORN AWAY FROM THE BOTTOM WEB. OBSERVATIONS AND TESTING: VISUAL/MICROSCOPIC EVALUATION: OBSERVED THE PROTECTIVE NEEDLE COVER WAS BROKEN AT THE TIP WITH A PIECE OF THE BROKEN PLASTIC (NEEDLE COVER) ATTACHED TO THE TIP OF THE TUBING OF THE CATHETER/ADAPTER ASSEMBLY AND ANOTHER PIECE LOOSE WITHIN THE COVER. MICROSCOPIC EVALUATION REVEALED THERE WAS FM (CLEAR SUBSTANCE) PRESENT ON THE OUTSIDE OF THE GRIP AND INSIDE THE PROTECTIVE NEEDLE COVER; WHERE THE TWO PORTIONS COME IN CONTACT WITH EACH OTHER. THE FM WAS IDENTIFIED TO BE NON-FOREIGN (EXCESSIVE GEL) THAT RESULTED FROM THE GEL DISPENSE PROCESS (ZONE 5A). NOTE THAT THE EXCESS GEL WAS EASILY REMOVED FROM THE BARREL/GRIP AND NEEDLE COVER WITH A SWAB STICK. CONFIRMATION OF THE DEFECT OF FOREIGN MATTER, WAS CONCLUSIVE BASED ON THE OBSERVATIONS OF THE UNIT PROVIDED. RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: THE CHARACTERISTICS OF THE FM (NON-FOREIGN / EXCESS GEL); WAS EVIDENCE TO CONFIRM AND SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT OF THE RETURNED UNIT; AS THE NON-FOREIGN (EXCESS GEL) WAS INTRODUCED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD A GEL LIKE SUBSTANCE PRESENT.

    Additional Manufacturer Narrative · 1

    (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 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD A GEL LIKE SUBSTANCE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972445 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8192723 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other