BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD

    MDR report key: 9273677 · Received November 4, 2019

    Report

    Report Number
    1710034-2019-01170
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 4, 2019
    Report Date
    November 27, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A PHOTOGRAPH DISPLAYING BOTH PACKAGES TO BE PARTIALLY OPENED AT THE TOP OF THE BLISTER PACKAGES. THE REPORTED ISSUE WAS CONFIRMED. ALTHOUGH IT WAS CONFIRMED, THE PHOTO PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE ALLEGED FAILURE OR TO ESTABLISH A DEFINITE ROOT CAUSE. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. DHR WAS PERFORMED AND NO QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STERILE BREACH OCCURRED BEFORE USE WITH 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFECTIVE PACKAGE. PRESENCE OF 2 LOTS OF CATHETERS FOUND WITH OPEN OR READY-TO-PEEL PACKAGING IN ALL EMERGENCY BAGS." 2 OCCURRENCES REPORTED.

    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 #: 7282816. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2017-10-09. MEDICAL DEVICE LOT #: 7152643. MEDICAL DEVICE EXPIRATION DATE: 2020-05-31. DEVICE MANUFACTURE DATE: 2017-06-01. 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 STERILE BREACH OCCURRED BEFORE USE WITH 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DEFECTIVE PACKAGE PRESENCE OF 2 LOTS OF CATHETERS FOUND WITH OPEN OR READY-TO-PEEL PACKAGING IN ALL EMERGENCY BAGS." 2 OCCURRENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065389 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other