BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7563243 · Received June 1, 2018

    Report

    Report Number
    9610048-2018-00066
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 21, 2018
    Report Date
    October 4, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811442
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: OUR QUALITY ENGINEER WAS ABLE TO VERIFY THE REPORTED COMPLAINT OF FOREIGN MATTER ON THE DEVICE FROM THE SAMPLE RECEIVED. FOURIER-TRANSFORM INFRARED SPECTROSCOPY WAS ABLE TO VERIFY THE FOREIGN MATTER WAS COMPOSED OF CELLULOSE, LIGNIN, AND SILICONE ON THE CATHETER WHICH APPEARS TO BE A CARDBOARD PARTICLE. DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY# 008653BJF LOT 7045710 MANUFACTURED FROM 20-FEB-17 TO 24-FEB-17 IN ACAM01 MACHINE USED IN CLAIMED LOT 7173829. THIS LOT WAS REVIEWED REGARDING THE TESTS OF ¿FOREIGN MATTER¿ AND NO RECORDS WERE FOUND THAT COULD LEAD TO THE CLAIMED DEFECT. IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OR THE SOURCE OF THIS TYPE OF MATERIAL, SINCE THE USE OF CARDBOARD INSIDE THE PRODUCTION AREAS IS NOT ALLOWED, THE FINAL ASSEMBLY MACHINE IS ENCLOSED AND THE PRODUCT REMAINS WITH THE NEEDLE COVER FROM FINAL ASSEMBLY TO THE PRODUCT PACKAGING. THUS, IT WAS NOT POSSIBLE TO DETERMINE HOW A PARTICLE OF THIS NATURE REACHED THE CATHETER EVEN WITH THE PRESENCE OF THE NEEDLE COVER. 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.

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018. PREVIOUSLY FILED EMDR'S DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD ANGIOCATH¿ IV CATHETER THERE WAS AN ISSUE WITH FOREIGN MATTER INSIDE THE SEALED DEVICE PACKAGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD ANGIOCATH IV CATHETER THERE WAS AN ISSUE WITH FOREIGN MATTER INSIDE THE SEALED DEVICE PACKAGE. 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 ANGIOCATH¿ IV CATHETER THERE WAS AN ISSUE WITH FOREIGN MATTER INSIDE THE SEALED DEVICE PACKAGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404909 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7173829 30382903811442

    Patients

    Seq Age Sex Outcome Treatment
    1 Other