BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 8152116 · Received December 11, 2018

    Report

    Report Number
    1710034-2018-00897
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 25, 2018
    Report Date
    February 14, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    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: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER HAD STERILITY BREACH. IT OCCURRED 15,26 AND 8 TIMES WITH BATCHES 7268945, 7222624 AND 7282722 RESPECTIVELY. INVESTIGATION: A DHR WAS PERFORMED FOR THE 3 REPORTED LOTS AND REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THESE LOTS THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT REPORTED. WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. IT COULD HAVE BEEN AN ISSUE WITH SUPPLIER MATERIAL, BUT CAN¿T BE CONFIRMED. A CAPA WAS COMPLETED FOR A LOW LEVEL SUPPLIER DEFECT IN THE TOP WEB THAT WOULD HAVE LOW PULL STRENGTH, EVEN THOUGH ALL MANUFACTURING SPECIFICATION WERE MET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER HAD STERILITY BREACH. IT OCCURRED 15,26 AND 8 TIMES WITH BATCHES 7268945, 7222624 AND 7282722 RESPECTIVELY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7268945. MEDICAL DEVICE EXPIRATION DATE: 2020-08-31. DEVICE MANUFACTURE DATE: 2017-09-25. MEDICAL DEVICE LOT #: 7222624. MEDICAL DEVICE EXPIRATION DATE: 2020-07-31. DEVICE MANUFACTURE DATE: 2017-08-10. MEDICAL DEVICE LOT #: 7282722. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2017-10-09." 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 CATHETER HAD STERILITY BREACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990047 INSYTE AUTOGUARD SHIELDED IV CATHETER PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.6 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other