BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSYTE AUTOG BC BLU

    MDR report key: 8187380 · Received December 20, 2018

    Report

    Report Number
    1710034-2018-00975
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 20, 2018
    Report Date
    January 25, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825234
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DHR- A TOTAL OF (B)(4) WERE MANUFACTURED ON AFA LINE 12 FROM 13JUL18 THROUGH 18JUL18 THERE WERE 3 INSTANCES WHERE THE CHALLENGE SAMPLES WERE NOT NOTED AS PASS OR FAIL (REJECT WEDGE CHALLENGE, PLUG DEPTH ATTRIBUTE CHALLENGE AND SPLAY LUBE CHALLENGE), OF WHICH NONE WERE RELATED TO THIS INCIDENT. **THESE NON-RECORDED (PASS/FAIL) CHALLENGES HAVE BEEN ADDRESSED BY THE QE. ALL OTHER CHALLENGE, SET UP AND IN PROCESS SAMPLES WERE PERFORMED AND ALL PASSED PER SPECIFICATIONS RECEIVED A TOTAL OF 12 IAG 22GA UNITS WITHIN SEALED PACKAGES ALONG WITH 3 EMPTY-OPEN PACKAGES FROM LOT NUMBER 8192723. ALL THE CONTENTS WITHIN THE SEALED PACKAGES WERE PRESENT. VISUAL EVALUATION: 4 OF THE 12 UNITS RECEIVED REVEALED DAMAGE (STRESS MARKS, PARTIAL BENDING) ON THE SAFETY BARREL. UPON PRESSING THE ACTIVATION BUTTON THE NEEDLE ONLY PARTIALLY RETRACTED, THE DAMAGE FOUND ON THE BARRELS PREVENTED FULLY RETRACTION. CONCLUSION: MANUFACTURING: THE NEEDLE RETRACTION FAILURE DESCRIBED IN THE INCIDENT REPORT WAS POTENTIALLY CAUSED BY THE DAMAGE (CRACKS, STRESS MARKS) FOUND ON THE SAFETY BARREL WHICH WAS CAUSED BY MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ INSYTE AUTOG BC BLU HAD A NEEDLE THAT FAILED TO RETRACT.

    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 A BD¿ INSYTE AUTOG BC BLU HAD A NEEDLE THAT FAILED TO RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027596 BD¿ INSYTE AUTOG BC BLU PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8192723 00382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other