BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE

    MDR report key: 15019710 · Received July 14, 2022

    Report

    Report Number
    3003152976-2022-00320
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 15, 2022
    Report Date
    July 18, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903008668
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, DAMAGE WAS OBSERVED ON THE SYRINGE BARREL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2110027, NO DEVIATIONS OR NON-CONFORMANCE'S 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. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, BASED ON THE PHOTO EVALUATION, IT IS LIKELY THE DAMAGE OCCURRED DURING THE ASSEMBLY PROCESS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. ONE PICTURE HAS BEEN RECEIVED TO PERFORM INVESTIGATION. COMPLAINT INVOLVES 50LL SYRINGE WITH REFERENCE 300866 AND LOT NUMBER 2110027. CUSTOMER REPORTS DAMAGE IN THE BARREL OF THE SYRINGE. DHR FROM LOT 2110027 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. UPON VISUAL INSPECTION OF THE PICTURE RECEIVED IT CAN BE SEEN DAMAGE IN THE BARREL OF THE SYRINGE. NO OTHER DEFECT CAN BE NOTICED. DAMAGE CAN BE PRODUCED WHEN SYRINGES ENTER IN THE SILICONE STATION, THEY MAY GET DAMAGED BY A TRIGGER. ACCORDING TO INSPECTION PLAN PROCEDURE JG-500, 200 UNITS ARE INSPECTED EVERY 2 PALLETS BY QUALITY CONTROL TEAM. IN ADDITION, FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED BY OPERATOR AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES (JG-301, JG-302, JG-303 AND JG-304). ALTHOUGH MANUFACTURING RECORDS ESTABLISHES ALL PRODUCTION AND MANUFACTURING RECORDS WERE CARRIED OUT NORMALLY, THE DAMAGE FOUND IN BARREL CAN BE RELATED TO ASSEMBLY PROCESS DURING MANUFACTURING. BASED ON ALL THE PREVENTIVE MEASURES AND OUR STRINGENT IN ¿PROCESS INSPECTION PLAN, WE ARE CERTAIN THAT THIS SHOULD BE AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY BASED ON NO QUALITY NOTIFICATION WAS OPENED DURING MANUFACTURING PROCESS OF THIS LOT. 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 QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, DAMAGE WAS OBSERVED ON THE SYRINGE BARREL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2110027 , 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. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, BASED ON THE PHOTO EVALUATION, IT IS LIKELY THE DAMAGE OCCURRED DURING THE ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN BARREL

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408637 50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 300866 2110027 30382903008668

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown