BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 16402251 · Received February 20, 2023

    Report

    Report Number
    3003916417-2023-00036
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    January 26, 2023
    Report Date
    March 20, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 01-MAR-2023. INVESTIGATION SUMMARY FIFTEEN SAMPLES AND PHOTOS RECEIVED FOR INVESTIGATION. UPON VISUAL EVALUATION, FOREIGN MATTER CAN BE OBSERVED. IT IS POSSIBLE TO OBSERVE THE PRESENCE OF LINT IN TWO UNITS. NO OTHER DEFECTS OR ISSUES FOUND. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. RETENTION SAMPLES FROM THE SAME LOT WERE EVALUATED, NO DEFECTS OR ISSUES OBSERVED. POSSIBLE ROOT CAUSE FOR FOREIGN MATTER IS DUE TO ACCUMULATION OF FINE BURRS DURING INJECTION PROCESS. ACTION WILL BE IMPLEMENTED, REPLACE GUARD FEEDER BRUSHES EVERY FOUR MONTHS, INSTALLATION OF A CLEANING SYSTEM FOR THE PROTECTORS THROUGH A SET OF PRESSURIZED AIR IONIZERS, WHICH INTENDS TO DISCHARGE THE MATERIAL ELECTRICALLY, REDUCING ITS STATIC CHARGE FOR SUBSEQUENT SUCTION OF THE PARTICLES RELEASED THROUGH VACUUM, AND IMPLEMENTATION OF A FINE BURR REDUCTION DEVICE. ANALYZING THE OTHER FOREIGN MATTER HIGHLIGHTED, IT IS POSSIBLE TO ATTRIBUTE THESE POINTS TO DIRT THAT CAME OFF THE PACKAGING MACHINE OR PROTECTOR ASSEMBLY, ANNUAL DEEP CLEANING HAS BEEN CARRIED OUT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2180498, MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027, DEVICE MANUFACTURE DATE: 29-JUN-2022. MEDICAL DEVICE LOT #: 2120736, MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027, DEVICE MANUFACTURE DATE: 30-APR-2022. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PRECISIONGLIDE¿ NEEDLE FOREIGN MATTER WAS FOUND IN 5 NEEDLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 OF BATCH 2180498 WITH FOREIGN MATTER; 2 OF BATCH 2120736 WITH FOREIGN MATTER;

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PRECISIONGLIDE¿ NEEDLE FOREIGN MATTER WAS FOUND IN 5 NEEDLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 OF BATCH 2180498 WITH FOREIGN MATTER. 2 OF BATCH 2120736 WITH FOREIGN MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676168 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown