BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8234879 · Received January 10, 2019

    Report

    Report Number
    1710034-2018-00990
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 21, 2018
    Report Date
    February 28, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814337
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON LOT NUMBER: 8151936; THE LOT NUMBER WAS BUILT ON AFA LINE 6 FROM 05JUN18 THRU 09JUN18 FOR A QUANTITY OF (B)(4) UNITS. PACKAGED ON PACKAGING LINE 11 FROM 13JUN19 THRU 14JUN19. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED ONE NON-RELATED QN WAS INITIATED ON THIS LOT THAT WOULD NOT IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. RECEIVED ONE USED IAG 24GA CATHETER/ADAPTER ASSEMBLY AND AN OPENED PACKAGE FROM CATALOG NUMBER: 381433, LOT NUMBER: 8151936. VISUAL/MICROSCOPIC EVALUATION: USING AN UNUSED CATHETER/ADAPTER ASSEMBLY; COMPARED THE LENGTH TO THE RETURNED USED CATHETER/ADAPTER. APPROXIMATELY 1/4 INCH OF THE CATHETER TUBING WAS MISSING FROM THE TIP THE AREA OF SEPARATION CATHETER TUBING EDGES WERE UNEVEN AND SMOOTH. PROBABLE ROOT CAUSE: INDETERMINATE ¿ ALTHOUGH THE DEFECT CATHETER BROKE/SEPARATED AFTER USED WAS CONFIRMED. THERE WAS NO PHYSICAL OR MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. PER THE EVENT DESCRIPTION: THE CATHETER TIP BROKE OFF AFTER REMOVAL. THE SHOWS THE CATHETER/ADAPTER WAS FUNCTIONING CORRECTLY DURING THE PERIOD OF USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER TIP BROKE OFF AFTER REMOVAL AND REMAINED IN THE PATIENT. THE CATHETER TIP "SHOWED ON X-RAY" AND WAS REMOVED BY THE HAND SURGEON IN THE OPERATING ROOM "WHILE PATIENT HAS THEIR PROCEDURE."

    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 THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER TIP BROKE OFF AFTER REMOVAL AND REMAINED IN THE PATIENT. THE CATHETER TIP "SHOWED ON X-RAY" AND WAS REMOVED BY THE HAND SURGEON IN THE OPERATING ROOM "WHILE PATIENT HAS THEIR PROCEDURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27184 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8151936 30382903814337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention