BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH PLUS¿ VENOUS CATHETER

    MDR report key: 7754091 · Received August 6, 2018

    Report

    Report Number
    8041187-2018-00265
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 17, 2018
    Report Date
    September 13, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 MANUFACTURER: YES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 1 PHOTO WAS RETURNED FOR INVESTIGATION. NO ABNORMALITIES WERE OBSERVED IN THE RETURNED PHOTO. 1 ACTUAL SAMPLE IN OPENED PACKAGING WAS RETURNED FOR INVESTIGATION. THE ACTUAL SAMPLE WAS SUBJECTED TO VISUAL INSPECTION. A CUT WAS OBSERVED ON THE CATHETER OF THE RETURNED SAMPLE. THE REPORTED FM WAS FOUND TO BE THE CATHETER TUBING MATERIAL DUE TO THE CUT. DEVICE HISTORY RECORD OF PACKAGED NEEDLE BATCH 8082170, CATALOGUE NUMBER 382434 AND ITS ASSEMBLED NEEDLE BATCHES 8053361 AND 8082075, PART NUMBER 8301331 WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. THE CUT COULD HAVE BEEN CAUSED BY CANNULA PIERCED THROUGH CATHETER. THE CANNULA PIERCED THROUGH CATHETER COULD HAVE OCCURRED DURING ASSEMBLY OF CATHETER AND CANNULA OR DURING PRODUCT APPLICATION WHEN THE PRODUCT WAS MANIPULATED. HOWEVER, THERE IS AN AUTOMATED VISION INSPECTION MACHINE, WHICH CAN DETECT AND REJECT PRODUCT WITH CANNULA PIERCED THROUGH CATHETER IN THE ASSEMBLY PROCESS. HENCE, THE ROOT CAUSE OF THE NONCONFORMANCE COULD NOT BE DETERMINED. THE TREND OF THIS NONCONFORMANCE WILL BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON THE BD ANGIOCATH PLUS¿ VENOUS CATHETER TUBE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON THE BD ANGIOCATH PLUS¿ VENOUS CATHETER TUBE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 THERE WAS FOREIGN MATTER ON THE BD ANGIOCATH PLUS¿ VENOUS CATHETER TUBE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594444 BD ANGIOCATH PLUS¿ VENOUS CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8082170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other