BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7789786 · Received August 16, 2018

    Report

    Report Number
    9610048-2018-00112
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    July 31, 2018
    Report Date
    September 7, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903811472
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 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: YES. AS PER REQUEST, (10) SAMPLES WERE RANDOMLY SELECTED FROM EACH REPORTED LOT NUMBER AND EXAMINED. ALL EXAMINED SAMPLES FROM EACH OF THE LOT NUMBERS EXHIBITED CLEAR DROPLETS OF MATERIAL ON THE SURFACE OF THE CATHETER. ONE REPRESENTATIVE SAMPLE FROM EACH OF THE REPORTED LOT NUMBERS WAS SELECTED AND A SMALL AMOUNT OF THE MATERIAL WAS REMOVED FROM EACH SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS SILICONE FOR EACH OF THE LOT NUMBERS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE LOTS 7270758, 7173832 REGARDING TESTS TO VERIFY "FOREIGN MATTER/VISIBLE SILICONE" AND NO RECORDS WERE FOUND THAT COULD LEAD TO THE CLAIMED DEFECT. CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMER COMPLAINT FOR THE CLAIMED DEFECT. BASED ON THE INVESTIGATIONS CONDUCTED FOR COMPLAINTS OF EXCESS SILICONE OF ANGIOCATH, IT HAS BEEN FOUND THAT THE ROOT CAUSE OF THIS ON THE CATHETER IS CAUSED BY THE EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING THE CATHETER SILICONIZATION PROCESS. (B)(4) HAS BEEN INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ANGIOCATH IV CATHETER HAD FOREIGN MATTER DESCRIBED AS "WATER LIKE" AND "STICKY" ON THE CATHETER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7270758; MEDICAL DEVICE EXPIRATION DATE: 2022-09-30; DEVICE MANUFACTURE DATE: 2017-10-27; MEDICAL DEVICE LOT #: 7173832; MEDICAL DEVICE EXPIRATION DATE: 2022-06-30; DEVICE MANUFACTURE DATE: 2017-07-12. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ANGIOCATH¿ IV CATHETER HAD FOREIGN MATTER DESCRIBED AS "WATER LIKE" AND "STICKY" ON THE CATHETER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629329 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SEE H.10 00382903811472

    Patients

    Seq Age Sex Outcome Treatment
    1 Other