BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 18002461 · Received October 25, 2023

    Report

    Report Number
    3003152976-2023-00480
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    September 4, 2023
    Report Date
    January 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    UNK
    Removal / Correction 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

    PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2212074, FINDING A QUALITY NOTIFICATION RELATED TO THE REPORTED INCIDENT. DURING MANUFACTURING, DAMAGE TO THE SYRINGE BARRELS WAS IDENTIFIED, REQUIRING ADDITIONAL INSPECTIONS TO BE PERFORMED AND INITIATING A PROJECT TO LOOK FURTHER INTO THE INCIDENT. TEN RETAINED SAMPLES OF LOT 2212074 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS IN THE SYRINGE BARREL WAS OBSERVED ON ANY OF THE DEVICES. FURTHER INVESTIGATION IDENTIFIED THE DAMAGE WAS OCCURRING DURING THE ASSEMBLY PROCESS. A PROJECT WAS INITIATED TO ADDRESS THIS ISSUE, THE REPORTED LOT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF ANY CORRECTIVE ACTIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT DEVICE PROBLEM CODE: A0203 - DEFECTIVE DEVICE

    Description of Event or Problem · 0

    MDR 3 OF 5 BD PLASTIPAK LUER-LOCK 50 ML SYRINGES FROM LOT 2212074, SOME OF WHICH HAVE A MORE OR LESS PRONOUNCED DEFECT ON THE BODY OF THE SYRINGE. REPORTED BY THE IDE OF LEAKS OR AIR GETTING INSIDE AT THE TIME OF USE. REPEATED 1/09, 4/09, 5/09 AND 6/09 WHEN PREPARING A PSE, I NOTICED A LEAK WHEN I PULLED TOWARDS THE ACE. I NOTICE THAT SEVERAL SYRINGES FROM THE SAME BATCH HAD A MANUFACTURING DEFECT. THE FAULTY BATCHES ARE DISCARDED. NO OTHER SYRINGES IN STOCK. PATIENT'S CURRENT CONDITION: NR ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: USE OF SYRINGES WITH FEWER DEFECTS.

    Description of Event or Problem · 0

    MDR 3 OF 5 BD PLASTIPAK LUER-LOCK 50 ML SYRINGES FROM LOT 2212074, SOME OF WHICH HAVE A MORE OR LESS PRONOUNCED DEFECT ON THE BODY OF THE SYRINGE. REPORTED BY THE IDE OF LEAKS OR AIR GETTING INSIDE AT THE TIME OF USE. REPEATED (B)(6) WHEN PREPARING A PSE, I NOTICED A LEAK WHEN I PULLED TOWARDS THE ACE. I NOTICE THAT SEVERAL SYRINGES FROM THE SAME BATCH HAD A MANUFACTURING DEFECT. THE FAULTY BATCHES ARE DISCARDED. NO OTHER SYRINGES IN STOCK. PATIENT'S CURRENT CONDITION: NR ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: USE OF SYRINGES WITH FEWER DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048519 SYRINGE 50ML LL SYRINGE, PISTON FMF BECTON DICKINSON 2212074 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown