BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 60 ML LUER-LOK¿

    MDR report key: 16889781 · Received May 8, 2023

    Report

    Report Number
    1911916-2023-00281
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    April 14, 2023
    Report Date
    September 22, 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: 21-SEP-2023. H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS LEAKING THROUGH THE PLUNGER. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS AN EMPTY SYRINGE IN A PLASTIC BAG. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. SINCE COMPLAINTS CONTINUE TO BE LOGGED FOR THIS SYMPTOM WHEN USING CHEMOTHERAPY MEDICATIONS, A REQUEST FOR FURTHER ANALYSIS AND TESTING OF THE SAMPLE WILL BE MADE TO THE MDS DESIGN CENTER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303552, LOT 2210365. 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 REPORTED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    E.1 INITIAL REPORTER PHONE #: (B)(6). B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: LIQUID LEAKED FROM THE PLUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE 60 ML LUER-LOK¿ LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: LIQUID LEAKED FROM THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860866 BD SYRINGE 60 ML LUER-LOK¿ PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2210365

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown