BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 60 ML LUER-LOK¿

    MDR report key: 16698887 · Received April 7, 2023

    Report

    Report Number
    1911916-2023-00213
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 20, 2023
    Report Date
    May 1, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    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: 27-APR-2023. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS LEAKAGE THROUGH THE PLUNGER. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS THEN TESTED FOR PRESSURE WATER LEAKAGE PAST THE STOPPER PER IT21 AND THE SAMPLE PASSED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303552, LOT 2210362. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: 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 SYRINGE 60 ML LUER-LOK¿ LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: IT SHOWED LEAKAGE THROUGH THE PLUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE 60 ML LUER-LOK¿ LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: IT SHOWED LEAKAGE THROUGH THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795744 BD SYRINGE 60 ML LUER-LOK¿ PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2210362

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown