BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 20ML LL S/SU

    MDR report key: 21355085 · Received February 11, 2025

    Report

    Report Number
    3003916417-2025-00009
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 23, 2025
    Report Date
    January 29, 2025
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463003782
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 20ML SYRINGE HAD A HAIR. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ANALYSIS OF THE PHOTO CONFIRMS THE CONTAMINATION BY A HAIR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 990687, LOT 3349251. INSPECTIONS WERE CARRIED OUT ACCORDING TO PLAN AND NO RECORD OF THIS DEFECT WAS OBSERVED. THERE WERE NO QUALITY OCCURRENCES OR MAINTENANCE EVENTS RELATED TO THIS INCIDENT. ESTABLISHED PROCESSES TO AVOID CONTAMINATION INCLUDE ANALYSIS OF RAW MATERIALS FROM SUPPLIERS AND OPERATOR GUIDANCE ON QUALITY PROCEDURES RELATED TO CLEANING AND CONSERVATION OF THE MANUFACTURING SITE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, BD WAS ABLE TO CONFIRM THE INCIDENT IN QUESTION. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK 20ML LL S/SU HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SPANISH TO ENGLISH: ACCORDING TO THE INDICATIONS, THE 20 ML SYRINGE HAS A FOREIGN PARTICLE (HAIR). 1 UNIT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 28, 2025 THE EVENT OCCURRED ON 01/23/2025 WITH THE PRODUCTION OF HEPARINS AT THE MIXING CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959492 BD SYRINGE PLASTIPAK 20ML LL S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 3349251 07891463003782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown