BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿

    MDR report key: 7777266 · Received August 13, 2018

    Report

    Report Number
    9610048-2018-00108
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    August 22, 2017
    Report Date
    September 14, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURE: NO. INVESTIGATION SUMMARY: BD WAS ABLE TO VERIFY THROUGH FOURIER-TRANSFORM INFRARED SPECTROSCOPY TESTING THAT THE MATERIAL ON THE RETURNED USED SAMPLE WAS BLOOD AND SILICONE. THE SILICONE COMES FROM THE CATHETER SILICONIZATION PROCESS, WHICH IS USED TO AID IN THE SLIPPAGE OF THE CATHETER DURING VENOUS PUNCTURE. NO OBJECTIVE EVIDENCE OF THIS INCIDENT WAS FOUND DURING THE DEVICE HISTORY RECORD AND QUALITY NOTIFICATIONS ANALYSIS FOR THE CLAIMED LOT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY 8016608, LOT 7241989 MANUFACTURED FROM 04-SEP-17 TO 26-SEP-17 AT ICAM #2 MACHINE. THIS LOT WAS REVIEWED REGARDING THE TESTS OF "FOREIGN MATTER" AND NO EVIDENCE WAS FOUND THAT COULD LEAD TO CLAIMED DEFECT. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NONCONFORMITY REPORT OF ¿FOREIGN MATTER¿ THAT COULD LEAD TO THIS COMPLAINT. BASED ON THE INVESTIGATION RESULTS TO DATE THE ROOT CAUSE WAS NOT DETERMINED FOR THE DEFECT OF THIS COMPLAINT. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED DEFECT WILL CONTINUE TO BE TRACKED AND TRENDED. THE INFORMATION WILL BE CAPTURED IN THE TREND REPORTS AND MONITORED MONTHLY. COLLECTED DATA ARE REGULARLY REVIEWED TO IDENTIFY EMERGING TRENDS. BASED ON THIS, A CAPA IS NOT NEEDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    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 WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620579 BD INSYTE¿ AUTOGUARD¿ INTRAVENOUS CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7241986

    Patients

    Seq Age Sex Outcome Treatment
    1 Other