BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE

    MDR report key: 8412545 · Received March 12, 2019

    Report

    Report Number
    1213809-2019-00320
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 25, 2019
    Report Date
    May 2, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE PHOTOS AND ONE LOOSE USED 1ML LL SYRINGE INSIDE AN OPENED BLISTER PACKAGE FROM BATCH #7240915 (P/N 309628) WERE RECEIVED AND VISUALLY EVALUATED. THE STOPPER WAS FOUND TO HAVE SEVERE DEFORMITIES TO IT'S FRONT AND BACK RIBS, POSSIBLY DUE TO DAMAGE. THE DEFORMITIES PREVENTED THE STOPPER FROM FORMING A SEAL WITH THE BARREL WALL. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE FOR THE DEFECTIVE STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 7240915 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ DISPOSABLE SYRINGE COULD NOT EXTRACT LIQUID BECAUSE OF A DEFECTIVE STOPPER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "DOCTOR FEEDBACK USING SYRINGE COULDN'T EXTRACT LIQUID, THERE WAS NO NEGATIVE PRESSURE. IT WAS FOUND THERE WAS STOPPER DEFECTIVE IN PLUNGER."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ DISPOSABLE SYRINGE COULD NOT EXTRACT LIQUID BECAUSE OF A DEFECTIVE STOPPER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "DOCTOR FEEDBACK USING SYRINGE COULDN'T EXTRACT LIQUID, THERE WAS NO NAGATIVE PRESSURE. IT WAS FOUND THERE WAS STOPPER DEFECTIVE IN PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208191 BD LUER-LOK DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7240915 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other