BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 14733675 · Received June 17, 2022

    Report

    Report Number
    3003152976-2022-00274
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    April 17, 2022
    Report Date
    June 1, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2201089, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED DURING MANUFACTURING. DAMAGE CAN OCCUR DUE TO THE PRODUCT JAMMING WITHIN MANUFACTURING EQUIPMENT. WITHOUT THE SAMPLE TO EVALUATE, WE CANNOT VERIFY THIS TO BE TRUE FOR THE INCIDENT REPORTED. BASED ON THE AVAILABLE INFORMATION WE CANNOT IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES LEAKAGE OCCURRED FROM A HOLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF OCCURRENCE: (B)(6) 2022. INCIDENT DESCRIPTION: A DEPARTMENT REPORTED TO US A LEAK OF NOREPINEPHRINE SOLUTION DURING SYRINGE PREPARATION. ON VISUAL INSPECTION CLEARLY SHOWS THAT THE BODY OF THE SYRINGE WAS ALREADY DAMAGED AND THAT THIS SYRINGE SHOULD HAVE BEEN IMMEDIATELY DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351358 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2201089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown