BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7696063 · Received July 17, 2018

    Report

    Report Number
    9610048-2018-00089
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    May 28, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: OUR QUALITY ENGINEER WAS UNABLE TO VERIFY THE REPORTED COMPLAINT. PHOTOS OR SAMPLES ARE NOT AVAILABLE FOR ANALYSIS. DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY #8607679 LOT 8057538 MANUFACTURED FROM 02-MAR-18 TO 29-MAR-18 USED IN CLAIMED LOT 8080622. 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. QN/ NCMR REVIEW: IT WAS EVIDENCED QN #(B)(4) FOR THE "GEL WEIGHT OUT OF SPECIFIED" DEFECT. HOWEVER, IT CANNOT AFFIRM THAT THIS NONCONFORMITY IS DIRECTLY RELATED TO THIS DEFECT. UNPLANNED MAINTENANCE: THE CORRECTIVE MAINTENANCE HISTORY IN THE MANUFACTURING PERIOD OF THE ASSEMBLY LOT INVOLVED IN THIS COMPLAINT WAS EVALUATED AND NO RECORDS WERE RECORDED THAT COULD CLEARLY INDICATE A FAILURE OF THE ACTIVATION OF THE PART. FMEA ANALYSIS: THE ANALYSIS OF THE FMEA, DFPR054-0, VERSION 2, WAS CARRIED OUT IN THE PROCESS STEPS: LOAD THE GRIP; LOAD BUTTON; LOAD HUB; SPRING PRESENCE CHECK STATION; UNLOAD PALLETS FROM ZONE 3; LOAD ZONE 3 TRANSFER RAIL; GLUE DISPENSER; GLUE INSPECTION; CANNULATION LUBRICATION; TRANSFER RAIL LOADING; ASSEMBLY OF ZONE 4 LOADED ON THE PALLET; PLUG PLACEMENT STATION; PUT THE BARREL IN THE PART AND NO CHANGE WAS NECESSARY AT THIS TIME, SINCE THE RISKS ARE WITHIN ACCEPTABLE LIMITS ACCORDING TO RISK CATEGORY. ALTHOUGH A QUALITY NOTIFICATION OF GEL WEIGHT OUT OF SPECIFIED HAS BEEN EVIDENCED IN THE SUBASSEMBLY LOT USED IN THE CLAIMED LOT, IT IS NOT POSSIBLE TO DETERMINE THAT THIS NON-CONFORMITY IS RELATED TO THIS COMPLAINT. IN ADDITION, NO SAMPLES WERE RECEIVED FOR ANALYSIS, NOR WERE THERE ANY RECORDS THAT COULD LEAD TO THIS CLAIM DURING THE ANALYSIS OF THE BATCH HISTORY AND CORRECTIVE MAINTENANCE. BASED ON THE RESULTS OF THE INVESTIGATION TO DATE A ROOT CAUSE HAS NOT BEEN DETERMINED FOR THE DEFECT DESCRIBED IN THIS COMPLAINT, SINCE THE PRESENCE OF THE SAMPLE PROBLEM IS FUNDAMENTAL TO DETERMINING A POSSIBLE ROOT CAUSE. IT WAS NOT POSSIBLE TO CONFIRM THIS COMPLAINT AS BEING GENERATED BY MANUFACTURING PROCESS. 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 EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: SEX: FEMALE; EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURE: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD NEEDLE RETRACTION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD SHIELDED IV CATHETER HAD NEEDLE RETRACTION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    (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 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD NEEDLE RETRACTION FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535467 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8080622 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other