BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6989144 · Received October 30, 2017

    Report

    Report Number
    1710034-2017-00285
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    October 5, 2017
    Report Date
    October 11, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814238
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION: INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 7193609 ¿ THE LOT NUMBER WAS BUILT ON AFA LINE 2, FROM JULY 17, 2017 THRU JULY 25, 2017. THE REVIEW OF THE DHR REVEALED: ACCORDING TO THE LINE CLEARANCE FOR ZONE 5; THE PREVIOUS WORK WAS ITEM NUMBER WAS NS381523, LOT NUMBER 2142680 7193609 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING 11, FROM JULY 21, 2017 THRU JULY 26, 2017. THE REVIEW OF THE DHR REVEALED: ACCORDING TO THE LINE CLEARANCE POSITIONS A, B AND C; THE PREVIOUS WORK WAS ITEM NUMBER WAS NS381444, LOT NUMBER 7191687. OBSERVATIONS AND TESTING: RECEIVED ONE UNUSED IAG 22GA UNIT IN A SEALED PACKAGE FROM THE LOT NUMBER 7193609. OBSERVED THE PRODUCT INSIDE OF THE SEALED PACKAGE WAS AN 18GA UNIT. THE PRINT ON THE PAPER TOP WEB SHOWS THAT THE REF # IDENTIFIES THE PRODUCT AS 381423; WHICH IS 22GA IAG. THE RETURNED UNIT PROVIDED FOR EVALUATION REVEALED 18GA UNIT SEALED IN22GA PACKAGE. INVESTIGATION CONCLUSION: THE DEFECT OF LABEL CONTENT INCORRECT; AS STATED IN THE SUBJECT OF THE PIR WAS CONFIRMED WITH THE RETURNED UNIT. THE PRINT ON THE PAPER TOP WEB SHOWS THAT THE REF # IDENTIFIES THE PRODUCT AS 381423; WHICH IS 22GA IAG. THE PRODUCT INSIDE THE SEALED PACKAGE IS AN 18GA UNIT. THE CUSTOMER EXPERIENCED WAS CONFIRMED WITH THE EVALUATION PERFORMED ON THE RETURNED UNIT. ROOT CAUSE DESCRIPTION: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: PACKAGING PROCESS COMMENT: THE PRODUCT ASSOCIATED WITH THIS INCIDENT WAS CAUSED BY AN INADEQUATE LINE CLEARANCE PER THE PACKAGING LINE CLEARANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN 18 G CATHETER WAS FOUND IN A 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER PACKAGE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766399 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7193609 30382903814238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other