BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 10144005 · Received June 11, 2020

    Report

    Report Number
    1213809-2020-00390
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    March 22, 2020
    Report Date
    June 19, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY ONE PHOTO WAS PROVIDED TO EVALUATE FOR THIS RECORD. SAMPLE EVALUATION CONFIRMED THE JAMMED STOPPER CONDITION OBSERVED BY AMGEN. THIS PRODUCT IS MANUFACTURED IN ACCORDANCE WITH ISO:7886-1 AND OUR PRODUCT SPECIFICATION. NO CONTAINMENT ACTIONS ARE NECESSARY AS THERE IS NO REMAINING INVENTORY OF LOT #9150915 IN BD CONTROL. THE DEFECT IS BELIEVED TO BE ISOLATED IN NATURE AND THE SCOPE IS THEREFORE LIMITED TO A SMALL PORTION OF THIS LOT ONLY. THIS IS THE ONLY RELATED COMPLAINT RECEIVED FOR THIS DEFECT ON THIS LOT OF THIS MATERIAL. PRODUCTION RECORDS AND MATERIAL MOVEMENT WERE REVIEWED, A TECHNICIAN WAS INTERVIEWED, AND MACHINE OPERATION AND EQUIPMENT WERE EVALUATED. AFTER CONSIDERATION OF POTENTIAL FAILURE MODES, THE MOST PROBABLE ROOT CAUSE FOR THE JAMMED STOPPER DEFECT WAS IDENTIFIED TO BE ASSEMBLY PROCESS FAILURE. A JAM IN THE ASSEMBLY DIALS MOST LIKELY CAUSED MISALIGNMENT WHEN THE PLUNGER ROD WAS INSERTED INTO THE BARREL. IT IS POSSIBLE NOT ALL DEFECTIVE PARTS WERE DISCARDED AND A SMALL LIMITED NUMBER WITH THIS DEFECT ENDED UP GETTING MIXED WITH THE GOOD PRODUCT. THE DEFECTIVE RATE IDENTIFIED IS 1 OUT OF 302,400, WHICH IS 0.0003%. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9150915 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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 AN UNSPECIFIED NUMBER OF BD 1ML SYRINGES LUER-LOK¿ TIPS EXPERIENCED DEFECTIVE/DAMAGED STOPPERS. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 22-MAR-2020, DISTRIBUTOR WAS NOTIFIED OF ONE PLUNGER ROD THAT WAS OBSERVED WITH A DEFORMED STOPPER. THE COMPLAINTS DESCRIPTION FROM THE PATIENT STATED THAT "THE PLUNGER ROD HEAD WAS NOT IN THE CORRECT POSITION".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 1ML SYRINGES LUER-LOK¿ TIPS EXPERIENCED DEFECTIVE/DAMAGED STOPPERS. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, DISTRIBUTOR WAS NOTIFIED OF ONE PLUNGER ROD THAT WAS OBSERVED WITH A DEFORMED STOPPER. THE COMPLAINTS DESCRIPTION FROM THE PATIENT STATED THAT "THE PLUNGER ROD HEAD WAS NOT IN THE CORRECT POSITION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610060 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9150915 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other