BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-W¿ IV CATHETER

    MDR report key: 8805206 · Received July 18, 2019

    Report

    Report Number
    8041187-2019-00555
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 14, 2019
    Report Date
    October 23, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    30382903813125
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THREE HUNDRED AND EIGHTY THREE REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE SAMPLES RECEIVED, NO ABNORMALITIES WERE OBSERVED; THEREFORE, THE FAILURE CANNOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED UPON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER DAMAGE FOUND BEFORE USE WITH A BD INSYTE-W¿ IV CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT'S NOTICED THAT CATHETER BROKEN AFTER UNWRAPPING THE PACKAGE. DEFECTED PRODUCT COULDN'T BE USED. NO PHYSICAL HARM TO THE END USER." 385 OCCURRENCES WERE 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 #: 8053346, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2018-03-30. MEDICAL DEVICE LOT #: 8082127, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2018-03-23. MEDICAL DEVICE LOT #: 8170033, MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, DEVICE MANUFACTURE DATE: 2018-06-19. 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 CATHETER DAMAGE FOUND BEFORE USE WITH A BD INSYTE-W¿ IV CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT'S NOTICED THAT CATHETER BROKEN AFTER UNWRAPPING THE PACKAGE. DEFECTED PRODUCT COULDN'T BE USED. NO PHYSICAL HARM TO THE END USER." 385 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599389 BD INSYTE-W¿ IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10 30382903813125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other