BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSYTE AUTOGUARD

    MDR report key: 8475383 · Received April 2, 2019

    Report

    Report Number
    1710034-2019-00365
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 13, 2019
    Report Date
    July 5, 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

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE THREE PHOTOGRAPHS PROVIDED. ALL THREE PHOTOS DISPLAYED YELLOW PLASTIC BAGS THAT CONTAINED IV CATHETER PRODUCT. BASED ON THE EVALUATION OF THE SUBMITTED PHOTOS; THE PHOTOS DID NOT REVEAL ANY VISIBLE ANOMALIES OR DAMAGE THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. THE SOURCE COULD NOT BE CONFIRMED WITHOUT THE ACTUAL UNITS FOR OBSERVATION AND/OR EVALUATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ INSYTE AUTOGUARD HAD THE PACKAGING WITH ONE OF ITS ENDS UNCOVERED. FOREIGN COMPLAINTS THE FOLLOWING INFORMATION WAS PROVIDED BY INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: ¿ DEVICE THAT HAS ITS PACKAGING WITH ONE OF ITS ENDS UNCOVERED BY ISSUES INHERENT TO THE MANUFACTURER.¿

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: 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 HAD THE PACKAGING WITH ONE OF ITS ENDS UNCOVERED. FOREIGN COMPLAINTS THE FOLLOWING INFORMATION WAS PROVIDED BY INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ¿ DEVICE THAT HAS ITS PACKAGING WITH ONE OF ITS ENDS UNCOVERED BY ISSUES INHERENT TO THE MANUFACTURER. ¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269652 BD¿ INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10. 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other