BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8255868 · Received January 17, 2019

    Report

    Report Number
    9610048-2018-00226
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    December 28, 2018
    Report Date
    March 19, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY CAT#8607681 LOT 8178728 MANUFACTURED FROM 11-JUL-18 TO 31-JUL-18 USED IN CLAIMED LOT 8191865. THE BATCH WAS ANALYZED FOR "NEEDLE RETRACTION" AND ¿PART ACTIVATION¿ TESTS, AND IT WAS NOT EVIDENCED RECORD OF FAILURE OF ACTIVATION OF THE PART DURING THE ANALYSIS OF THESE LOTS. IT WAS RECEIVED AT BD JUIZ DE FORA ON 02/04/2019, 1 UNIT IN OPENED PACKAGE OF THE PRODUCT INSYTE AUTOGUARD PNK 20GA X 1.16IN; CATALOG: 38183414; LOT: 8191865. ACCORDING TO ANALYSIS PERFORMED BY JUIZ DE FORA TEAM ON (B)(6) 2019, THE SAMPLE WAS RECEIVED IN OPENED PACKAGE AND THIS SAMPLE WAS RETRACTED WHEN THE BUTTON WAS PRESSED. CONCLUSION(S): NOT CONFIRMED: BD WAS UNABLE TO CONFIRM THE COMPLAINT FOR THE DEFECT CLAIMED. THERE WAS NO QN OR NON-CONFORMITY RELATED TO THIS COMPLAINT, THE SAMPLE RECEIVED FOR ANALYSIS DID NOT PRESENT THE DEFECT CLAIMED AND NO RECORDS WERE EVIDENCED THAT COULD LEAD TO THIS CLAIM DURING THE ANALYSIS OF BATCH HISTORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER PERFORMING THE PUNCTURE, THE SAFETY MECHANISM OF A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER COULD NOT BE ACTIVATED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). 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 AFTER PERFORMING THE PUNCTURE, THE SAFETY MECHANISM OF A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER COULD NOT BE ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49656 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8191865 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other