BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8148451 · Received December 10, 2018

    Report

    Report Number
    1710034-2018-00901
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 25, 2018
    Report Date
    February 14, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    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

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 300 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WERE FOUND TO HAVE POOR ADHERENCE TO THEIR PRIMARY PACKAGING, LOSING STERILITY. H.6. INVESTIGATION: DHR'S WERE PERFORMED ON THE 4 REPORTED LOTS AND THERE WERE QN'S RELATING TO THE QUALITY OF THE PRODUCT RELATED TO THE DEFECT. THERE WAS ONE QN FOR LOT# 8060626 THAT WAS NOT RELATED TO THE COMPLAINT. THE PHOTO SUBMITTED FOR REVIEW DISPLAYED NINE PACKAGES WITH EITHER THE TOP OR BOTTOM OF THE BLISTER PACK PARTIALLY OPENED. BD SUPPLIER OLIVER-TOLAS (OT) 29LP USES A STANDARD REINFORCED PAPER THAT IS COMMON TO MANY OTHER SUPPLIERS, BUT THE ADHESIVE TYPE AND APPLICATION IS SPECIFIC TO OLIVER-TOLAS. THERE IS SUFFICIENT EVIDENCE TO DEMONSTRATE THE OT MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE. DUE TO CONTINUOUS ISSUES WITH OT, BD MOVED TO AN ALTERNATE SUPPLIER FOR THE TOP WEB MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 300 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WERE FOUND TO HAVE POOR ADHERENCE TO THEIR PRIMARY PACKAGING, LOSING STERILITY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7299847. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2017-10-26. MEDICAL DEVICE LOT #: 8060626. MEDICAL DEVICE EXPIRATION DATE: 2021-02-28. DEVICE MANUFACTURE DATE: 2018-03-01. MEDICAL DEVICE LOT #: 7282659. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2017-10-09. MEDICAL DEVICE LOT #: 7342810. MEDICAL DEVICE EXPIRATION DATE: 2020-11-30. DEVICE MANUFACTURE DATE: 2017-12-08. 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 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WERE FOUND TO HAVE POOR ADHERENCE TO THEIR PRIMARY PACKAGING, LOSING STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987886 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other