BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8951907 · Received August 30, 2019

    Report

    Report Number
    1710034-2019-00954
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 12, 2019
    Report Date
    September 20, 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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CHANGES ARE AS FOLLOWS: E.1. INITIAL REPORTER ADDRESS 1: (B)(6).

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR REVIEW FOR LOT 9071791; WAS PREVIOUSLY CONDUCTED FOR INVESTIGATION (PR1053550-1074964 CR), WHICH DISCLOSED THE FOLLOWING: LOT WAS BUILT AND PACKAGED ON AFA LINE 12 FROM 22MAR2019 THROUGH 25MAR2019 FOR A QUANTITY OF 475,210 EA. ALL CHALLENGES, SET UP AND IN-PROCESS SAMPLES WERE PREFORMED ACCORDING TO THE QUALITY CONTROL PLAN. THERE WERE NO INDICATIONS OF THE ALLEGED DEFECT DURING THE PRODUCTION OF THIS LOT. SAP (QN) WAS CONDUCTED FOR THIS INVESTIGATION WHICH REVEALED THAT THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE REPORTED DEFECT ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT. ROOT CAUSE: INDETERMINATE ¿ ¿ NO UNITS (SAMPLES) OR PHOTOS WERE PROVIDED FOR OBSERVATION OR TESTING OF THIS INCIDENT THEREFORE THE ALLEGED DEFECT WAS NOT IDENTIFIED OR CONFIRMED AND A ROOT CAUSE WAS NOT ESTABLISHED. ¿ THEREFORE THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE ALLEGED DEFECT. 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. PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND/OR PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE RETRACTION FAILURE OCCURRED DURING USE WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLE DID NOT DROP INTO SAFETY CARTRIDGE WHEN BUTTON WAS HIT 3 TIMES AFTER IV PLACEMENT. AN ADDITIONAL NURSE PICKED UP THE NEEDLE AND ALSO ATTEMPTED TO CLICK BUTTON TO RETRACT NEEDLE FOR SAFETY WITHOUT IT WORKING. NEEDLE WAS CAREFULLY DROPPED INTO SAFETY SHARPS CONTAINER. NO INJURY OCCURRED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE RETRACTION FAILURE OCCURRED DURING USE WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLE DID NOT DROP INTO SAFETY CARTRIDGE WHEN BUTTON WAS HIT 3 TIMES AFTER IV PLACEMENT. AN ADDITIONAL NURSE PICKED UP THE NEEDLE AND ALSO ATTEMPTED TO CLICK BUTTON TO RETRACT NEEDLE FOR SAFETY WITHOUT IT WORKING. NEEDLE WAS CAREFULLY DROPPED INTO SAFETY SHARPS CONTAINER. NO INJURY OCCURRED."

    Additional Manufacturer Narrative · 1

    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 A NEEDLE RETRACTION FAILURE OCCURRED DURING USE WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLE DID NOT DROP INTO SAFETY CARTRIDGE WHEN BUTTON WAS HIT 3 TIMES AFTER IV PLACEMENT. AN ADDITIONAL NURSE PICKED UP THE NEEDLE AND ALSO ATTEMPTED TO CLICK BUTTON TO RETRACT NEEDLE FOR SAFETY WITHOUT IT WORKING. NEEDLE WAS CAREFULLY DROPPED INTO SAFETY SHARPS CONTAINER. NO INJURY OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743688 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9071791 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other