BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7072356 · Received November 30, 2017

    Report

    Report Number
    1710034-2017-00415
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 9, 2017
    Report Date
    December 19, 2017
    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 · 1

    RESULTS - BD RECEIVED 2 IAG 14GA UNITS, ONE FROM LOT NUMBER 6042643 AND ONE FROM 5043918. 6042643: THE UNIT PACKAGE WAS OPEN AT BOTH ENDS. 5043918: THE UNIT PACKAGE WAS NOT OPEN. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. THIS CHARACTERISTIC WAS MET. IN ADDITION THE PAPER TOP WEB OF THE RETURNED UNIT WAS ANALYZED UNDER UV LIGHT. THE GLUE USED TO SEAL THE TOP AND BOTTOM WEBS IS UV FLUORESCENT. THE ANALYSIS REVEALED AN ADEQUATE OF TOP WEB ADHESIVE. THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND TOP WEB GLUE. BOTH OF THESE VARIABLES WERE LOOKED AT DURING THE INVESTIGATION. NO SIGNIFICANT ISSUES WERE FOUND DURING THE REVIEW OF THE DEVICE HISTORY RECORD. CONCLUSION - THE CUSTOMER EXPERIENCE WAS CONFIRMED BASED ON THE EVALUATION THAT WAS PERFORMED ON THE RETURNED UNITS. ALTHOUGH THE PACKAGES WERE OBSERVED TO BE PARTIALLY OPENED, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. CAPA (B)(4) HAS BEEN OPENED TO INVESTIGATE THE PACKAGE OPEN SEAL DEFECTS AND IMPLEMENT CORRECTIVE ACTIONS.

    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 #: 6042643; MEDICAL DEVICE EXPIRATION DATE: 01/31/2019; DEVICE MANUFACTURE DATE: 02/12/2016; MEDICAL DEVICE LOT #: 5043918; MEDICAL DEVICE EXPIRATION DATE: 2/28/2018; DEVICE MANUFACTURE DATE: 2/11/2015. 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 BEFORE USE A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS FOUND WITH ¿THE PACKAGING OPENED OR PEELED BACK, MAKING THE PRODUCT NOT STERILE & OPEN TO AIR¿. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852251 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10. 30382903814672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other