BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7926793 · Received October 2, 2018

    Report

    Report Number
    1710034-2018-00731
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    August 24, 2018
    Report Date
    November 14, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT: ONE USED 24GA INSYTE AUTOGUARD IV CATHETER UNIT WAS RECEIVED WITHIN AN OPENED PACKAGE FROM LOT 7151567. OTHER THAN BEING OPENED THE PACKAGING REVEALED NO DAMAGE. THE IV CATHETER UNIT WAS WITH ALL COMPONENTS PRESENT AND INTACT. PHOTO: ONE PHOTO WAS PROVIDED FOR THIS INCIDENT WHICH REVEALED A 24GA BD INSYTE AUTOGUARD UNIT WHICH WAS OUT OF PACKAGING AND USED. THE UNIT CONSISTED OF THE CATHETER/ADAPTER ASSEMBLY AND THE NEEDLE/HUB ASSEMBLY WITH GRIP AND BARREL WITH THE PROTECTIVE NEEDLE COVER REMOVED. THE NEEDLE OF THE IV CATHETER WAS PIERCING THOUGH THE TUBING WALL NEAR THE TIP. THERE WAS ALSO VISIBILITY OF THE TOP WEB (TYVEK/LABEL) FROM A 24GA BD INSYTE AUTOGUARD FROM LOT 7151567. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF CATHETER DEFECTIVE/DAMAGED WITH LOT #7151567 REGARDING ITEM (B)(4). DHR REVIEW FOR LOT 7151567; WAS BUILT AND PACKAGED ON AFA LINE 4 FROM (B)(6) 2017 THROUGH (B)(6) 2017 AND PACKAGED ON LINE 9 FROM (B)(6) 2017 THROUGH (B)(6) 2017 FOR THE QUANTITY OF (B)(6) EA. ALL CHALLENGE, SET-UP AND IN PROCESS SAMPLES WERE PERFORMED IN ACCORDANCE TO THE QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. THERE WAS NO INDICATION OF THE DEFECT AS IT WAS NOTED THAT THERE WERE NO RELATED REJECT FINDINGS DURING PRODUCTION OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT; THERE WAS ONE NON-RELATED IP QN INITIATED DURING THIS BUILD. THERE WERE 2 NON-RELATED TEMPORARY DEVIATIONS IN EFFECT DURING THE BUILD OF THIS LOT. SAP (QN) DATABASE REVIEW; THERE WERE NO RELATED REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT. ONE IP QN (B)(4) WRINKLE IN SEAL POCKET #10) WAS INITIATED FOR THIS LOT. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN. ANALYSIS OF PEURA (END USER RISK ANALYSIS) DISCLOSED THAT DUE TO LOW OCCURRENCE AND LIMITED SEVERITY, CURRENT RISK IS ACCEPTABLE. ROOT CAUSE FOR THIS INCIDENT IS INDETERMINATE. ALTHOUGH THE UNIT AND PHOTO REVEALED A CATHETER DEFECTIVE/DAMAGED, IT WAS NOTED THAT BECAUSE THE UNIT WAS WITHIN AN OPENED PACKAGE AND POTENTIALLY USED IT WAS NOT KNOWN WHERE OR HOW THE NEEDLE THROUGH CATHETER (TIP SPEAR THRU) OCCURRED. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT STATED IN THE PIR. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE AUTOGUARD SHIELDED IV CATHETER, IT WAS DIFFICULT TO REMOVE THE NEEDLE FROM THE CATHETER SLEEVE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    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 WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER, IT WAS DIFFICULT TO REMOVE THE NEEDLE FROM THE CATHETER SLEEVE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768209 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7151567 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other