BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE PRECISIONGLIDE 21X1IN

    MDR report key: 10011688 · Received April 29, 2020

    Report

    Report Number
    3003916417-2020-00130
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    April 8, 2020
    Report Date
    April 9, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: THIS IS THE 1ST RELATED COMPLAINT FOR FM ON THE PROVIDED LOT NUMBER. IT WAS PERFORMED THE DHR REVIEW AND THE MANUFACTURING DATE FOR THIS BATCH WAS MARCH 11TH TO 16TH, 2020. THE PROCESS INSPECTIONS WERE PERFORMED AND NO RECORDS OF THIS INCIDENT WERE FOUND. THE CURRENT CONTROLS AT MANUFACTURING PROCESS TO DETECT THE INCIDENT ARE PERFORMED BY VISUAL INSPECTION EACH 02 HOURS AT 40 PARTS. BASED ON THE INCIDENT IN QUESTION THE BATCH HISTORY WAS ANALYZED. VISUAL INSPECTIONS OF THE PACKAGED PRODUCT ARE CARRIED OUT ACCORDING TO CONTROL PLAN, VALIDATED WITH THE ACCEPTABLE QUALITY LEVEL 0,15% (NQA) WITH THE FREQUENCY OF 2 HOURS AND ALWAYS ANALYZING 1 MACHINE CYCLE. 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. ALL RECORDS OF THE MANUFACTURE OF THE LOT PRESENTED RESULTS IN ACCORDANCE WITH THE SPECIFICATION. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO CONFIRM/ REPRODUCE THE INCIDENT IN QUESTION. SAMPLES/ PHOTOS ANALYSIS: IMAGE WAS RECEIVED, AND IT IS POSSIBLE OBSERVE FOREIGN MATTER - HAIR. ROOT CAUSE DESCRIPTION: IT WAS PERFORMED DHR AND MAINTENANCE EVALUATION AND NO OCCURRENCE WERE OBSERVED. BASED ON THIS EVALUATION THE POTENTIAL CAUSES FOR THE PROBLEM IS: THROUGH THE SAMPLE PROVIDED BY THE CUSTOMER IT WAS POSSIBLE TO OBSERVE THE PRESENCE OF FOREIGN MATTER - HAIR. ACCORDING THE INVESTIGATION EVIDENCES AND COMPLAINT DESCRIPTION INDICATING THAT THE DEFECT WAS GENERATED DURING THE NEEDLE PRODUCTION PROCESS. THE OPERATORS WILL BE NOTIFIED FROM THIS COMPLAINT. THE INCIDENT IDENTIFIED FROM THIS COMPLAINT WILL BE MONITORED FOR TREND EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE PRECISIONGLIDE 21X1IN CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRESENCE OF A STRAND OF HAIR IN THE PACKAGE, INTERNALLY, TOGETHER WITH THE MATERIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476028 NEEDLE PRECISIONGLIDE 21X1IN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 0059138

    Patients

    Seq Age Sex Outcome Treatment
    1 Other