BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALPAK 3ML BLUE HOSPITAL

    MDR report key: 8939917 · Received August 28, 2019

    Report

    Report Number
    3003916417-2019-00422
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    July 2, 2018
    Report Date
    August 27, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    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 · 1

    (B)(6). INVESTIGATION SUMMARY: THE BATCH HISTORY ANALYSIS WAS PERFORMED, QUALITY NOTIFICATIONS WERE VERIFIED, MAINTENANCE RECORDS AND NO DEVIATION WAS FOUND FOR THIS LOT. PHOTOS OF THE ORAL SYRINGE WERE AVAILABLE FOR ANALYSIS IN WHICH IT WAS POSSIBLE TO CONFIRM THE DEFECT OF FOREIGN MATERIAL - SPOT IN FUNCTION OF THE PRESENTED EVIDENCES. THE DEFECT WAS FOUND IN THE PLUNGER ROD COMPONENT THAT PRESENTED WITH DEGRADED MATERIAL AND IS RELATED TO THE BEGINNING OF THE PROCESS. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO CONFIRM/ REPRODUCE THE INCIDENT IN QUESTION. SAMPLE ANALYSIS: NO DEFECTIVE SAMPLE HAS BEEN SENT WITH DIRT SYRINGE FOREIGN MATTER HOWEVER THE PRESENTED DEFECT CAN BE CLASSIFIED AND ANALYZED AS FOREIGN MATTER - SPOT ANALYSIS OF BATCH HISTORY: LOT 8108700 IS COMPOSED OF BATCHES OF THE MOLDED COMPONENT PLUNGER ROD 8080663 AND 8088729 MANUFACTURED BETWEEN MARCH 1, 2018 AND APRIL 18, 2018. PLEASE BE ADVISED THAT FOR CYLINDERS, RODS, GUNS AND SAFETY GUARDS, VISUAL AND CASTING INSPECTIONS ARE CARRIED OUT IN THE MOLDING AREA, VALIDATED WITH THE ACCEPTABLE QUALITY LEVEL (NQA) OF 0.10% WITH THE FREQUENCY OF 4 TIMES PER SHIFT. BEFORE THE BATCH IS RELEASED TO THE CONSUMER, THE CONSUMER STILL GOES THROUGH THE PROCESS OF EVALUATION OF THE FINAL INSPECTION LABORATORY, WHERE MORE VALIDATED VISUAL TESTS ARE PERFORMED, CERTIFYING THE CONFORMITY OF THE PRODUCT. QN/ MAINTENANCE REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) AND MAINTENANCE RECORDS. CONCLUSION: DHR ANALYSIS WAS PERFORMED AND NO DEVIATION WAS FOUND. DURING THE ANALYSIS OF THE PHOTO WE SHOW THAT THERE IS FOREIGN MATERIAL EMBEDDED IN THE PLUNGER ROD FROM THE BURNED MATERIAL. THE COMPLAINT WAS RECORDED IN THE COMPLAINTS DATABASE WHICH IS REGULARLY MONITORED FOR TREND EVALUATION. ROOT CAUSE DESCRIPTION: THE PLUNGER ROD HAS BURNT MATERIAL, WHICH IS CHARACTERISTIC OF THE BEGINNING OF THE PROCESS. AS NO MOLD / MACHINE MAINTENANCE WAS EVIDENCED FOR THE ANALYZED PERIOD, IT IS POSSIBLE THAT THERE WAS A FAILURE IN THE MACHINE STARTUP PROCESS. DISPOSAL OF THE FIRST PARTS INJECTED DURING SETUP EXISTS AND IS CONTROLLED THROUGH THE CONTROL PLAN. UNDERSTANDING THAT THIS IS NOT A SYSTEMIC FAILURE, NO ACTION WILL BE TAKEN AT THIS TIME. THE COMPLAINT RATE FOR THE DEFECT IN QUESTION WILL BE MONITORED FOR FUTURE EVALUATION. RATIONALE: BASED ON SEVERITY AND OCCURRENCE A CAPA IS NOT NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF ORALPAK 3 ML BLUE HOSPITAL EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A DIRTY INSIDE THE SYRINGE. INFO ADD RECEIVED BY E-MAIL ON (B)(6) 2018: NOTICED PRIOR THE USE IN PATIENT. NO DAMAGE TO PATIENT OR TO PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732412 ORALPAK 3ML BLUE HOSPITAL SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 8108700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other