BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL BRAZIL

    MDR report key: 19049897 · Received April 5, 2024

    Report

    Report Number
    1911916-2024-00238
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Date of Event
    March 18, 2024
    Report Date
    May 1, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903035526
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9926317 FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WERE BLACK MARKS ON THE INSIDE OF THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARREL HAS BLACK SPECKS OF EMBEDDED DEGRADED RESIN. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE THREE PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. 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 RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHOWN TO THE ASSOCIATES FOR AWARENESS. 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 IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    PR 9926317: INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. AFTER OPENING THE PACKAGING OF THE 50 ML SYRINGE THAT WOULD BE USED TO DILUTE THE QT, WE NOTICED SOME BLACK MARKS (WHICH LOOKED LIKE INK) ON THE INSIDE OF THE SYRINGE. WE SEPARATED THE ITEM FOR COLLECTION AND ANALYSIS. AS RESPONSE RECEIVED ON 25MAR2024. HOW MUCH PRODUCT IS AFFECTED? PER HOUR, ONE UNIT IS THE SAMPLE CONTAMINATED? IF YES, STATE THE SUBSTANCE. NO. NOTHING WAS ASPIRATED WITH THIS PART HAS ANVISA BEEN NOTIFIED? IF SO, WHAT WAS THE NOTIFICATION NUMBER? NO - IS THE SAMPLE RELATED TO THE INCIDENT AVAILABLE FOR ANALYSIS? IF SO, HOW MANY UNITS? (WE COLLECT A MAXIMUM OF 10 UNITS FOR ANALYSIS PURPOSES). YES. 01 UNIT - FOR SAMPLE COLLECTION AND REPLACEMENT PURPOSES, PLEASE INDICATE: - CNPJ = 53678264/0002-46. - FULL ADDRESS AND POSTCODE = (B)(6) - CONTACT PERSON AND TELEPHONE NUMBER = - ICMS TAXPAYER (NOTA FISCAL ISSUER) (YES/NO) = NO. - PURCHASE INVOICE NUMBER = 1136534. - (B)(6) 10APR2024.

    Description of Event or Problem · 0

    AFTER OPENING THE PACKAGING OF THE 50 ML SYRINGE THAT WOULD BE USED TO DILUTE THE QT, WE NOTICED SOME BLACK MARKS (WHICH LOOKED LIKE INK) ON THE INSIDE OF THE SYRINGE. WE SEPARATED THE ITEM FOR COLLECTION AND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334285 SYRINGE 50ML LL BRAZIL SYRINGE, PISTON FMF BECTON DICKINSON 2210365 00382903035526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown