BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 19933437 · Received August 7, 2024

    Report

    Report Number
    9610048-2024-00122
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 16, 2024
    Report Date
    December 2, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38182314 AND POTENTIAL LOT NUMBERS 4092033, 4092040, AND 4092891. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE AND ONE (1) VIDEO SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE PICTURE SAMPLE PROVIDED THE PRODUCT INFORMATION, SUCH AS THE CATALOG NUMBER AND CALIBER. IN THE VIDEO SAMPLE, THE CUSTOMER WAS OBSERVED PRESSING ON THE TRIGGER BUTTON AND THE NEEDLE DID NOT RETRACT. IT IS POSSIBLE THAT THE OBSERVED DEFECT RESULTED FROM AN ISSUE WITH THE SPRING FORMATION IN THE MANUFACTURING PROCESS. SEVERAL CORRECTIONS WERE PREVIOUSLY CARRIED OUT FOR THIS POTENTIAL CAUSE, INCLUDING ADJUSTMENTS TO THE MACHINERY, CREATION OF PROCEDURES FOR THE RELATED MACHINERY CHECKS AND CHALLENGES, AND TRAINING OF THE INVOLVED ASSOCIATES. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: SAFETY DEVICE DID NOT ENGAGE TO RETRIEVE THE PROBE. - DATE OF OCCURRENCE OF THE EVENT? 16/07/2024 17 JUL - IS THERE ANY IMPACT FOR THE PATIENT RELATED TO THE EVENT ¿THE SAFETY DEVICE WAS NOT ACTIVATED TO COLLECT THE PROBE¿? NO, ONLY THE RISK TO THE EMPLOYEE WITH THE SHARPS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 26-AUGUST-2024: WITH REGARD TO THE QUESTION ASKED, THE ONLY EVENT WAS THAT THE PROBE DIDN'T RETRACT, AS AT THE TIME OF THE ADMISSIONS TRAY THERE WAS ANOTHER BATCH, WE COULDN'T IDENTIFY WHICH BATCH IT WAS, BECAUSE THERE WERE 3 BATCHES - PACKAGES IN THE TRAY FOR TWO PATIENTS THAT HAD ALREADY BEEN PUNCTURED AND THE PACKAGE REMAINED, AFTER SHE MADE THE ATTEMPT SHE LOOKED AT THE TRAY AND DIDN'T KNOW WHICH PACKAGE WAS THE ONE THAT DIDN'T RETRACT, SO I SENT YOU THE 3 BATCHES - THE PACKAGES ALL HAD SPECIFIED BATCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262017 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown