BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7694721 · Received July 17, 2018

    Report

    Report Number
    9610048-2018-00094
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 22, 2018
    Report Date
    October 8, 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

    ONE SAMPLE FROM EACH OF THE REPORTED LOT NUMBERS WAS RETURNED TO FLKS FOR FTIR ANALYSIS. AS PER REQUEST, ALL RETURNED SAMPLES WERE EXAMINED AN ALL EXHIBITED CLEAR DROPLETS OF MATERIAL ON THE SURFACE OF THE CATHETER. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM A REPRESENTATIVE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS SILICONE. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: 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.

    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.

    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. 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. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7173832; MEDICAL DEVICE EXPIRATION DATE: 2022-06-30; DEVICE MANUFACTURE DATE: 2017-07-12; MEDICAL DEVICE LOT #: UNKNOWN; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. 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. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535628 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SEE H.10 00382903811472

    Patients

    Seq Age Sex Outcome Treatment
    1 Other