BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE NRFIT¿ LOK

    MDR report key: 20563245 · Received October 29, 2024

    Report

    Report Number
    1213809-2024-00770
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    August 7, 2024
    Report Date
    November 27, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    QEH
    UDI-DI
    00382904001735
    PMA / PMN Number
    K192538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)- SUPPLEMENTAL MDR - STOPPER DEFECTIVE / DAMAGED. ONE PHOTO OF A 5ML NRFIT SYRINGE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTO SHOWS A CLOSE-UP IMAGE OF ONE LOOSE SYRINGE WITH THE STOPPER JAMMED BETWEEN THE BARREL AND THE PLUNGER ROD. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE STOPPER JAMMED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0013110. A NOTIFICATION FOR THIS DEFECT WAS WRITTEN DURING THE PRODUCTION OF THIS BATCH. A REQUALIFICATION WAS PERFORMED, AND THE LINE CLEARED OF DEFECTS. HOWEVER, IT IS POSSIBLE A LIMITED NUMBER OF PIECES WITH THIS CONDITION WERE ABLE TO ESCAPE DETECTION. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY, SO NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE NRFIT¿ LOK STOPPER WAS DEFECTIVE / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT NUMBER: BD® 5 ML SYRINGE NRFIT¿ LOK. REFERENCE NUMBER/SKU: (B)(4). LOT/SERIAL NUMBER: (B)(6). EXPIRATION DATE: 31-12-2024. PROBLEM ENCOUNTERED: ANOMALY OBSERVED IN THE STOPPER WHILE PULLING LIQUID INSIDE. ADDITIONAL INFORMATION PROVIDED: COULD YOU PLEASE PROVIDE EVENT OCCURRENCE DATE? 7TH AUGUST 2024. HAS THERE BEEN ANY PATIENT IMPACT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE OF TREATMENT REQUIRED)? NO, THE EVENT OCCURRED AS PART OF OUR INTERNAL TESTING FOR ASSESSING THE PERFORMANCE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964533 BD SYRINGE NRFIT¿ LOK PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT QEH BECTON DICKINSON MEDICAL SYSTEMS 0013110 00382904001735

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown