BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL

    MDR report key: 10224921 · Received July 2, 2020

    Report

    Report Number
    1213809-2020-00430
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    June 11, 2020
    Report Date
    July 10, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903050605
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO PHOTOS AND FOUR 3ML SYRINGES WERE RECEIVED AND EVALUATED. THREE OF THE SYRINGES WERE IN FULLY SEALED BLISTER PACKS CONFIRMED TO BE FROM BATCH 0041393 (P/N 305060) AND ONE WAS LOOSE. IT WAS OBSERVED THE PLUNGER AND STOPPER WERE OBSERVED TO BE AT 1ML GRAD LINE WITH WHAT APPEARED TO BE CLEAR LIQUID DROPLETS IN THE FLUID PATH. AN INSECURE STOPPER CONDITION WAS OBSERVED TO BE PRESENT IN THE SYRINGE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 0041393 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. A POTENTIAL ROOT CAUSE FOR THE INSECURE STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0041393 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL STOPPER WAS SEPARATING FROM THE PLUNGER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305060. BATCH NO: 0041393. IT WAS REPORTED THAT RUBBER STOPPER/PLUNGER PIECE DISLODGING UPON DRAW.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL STOPPER WAS SEPARATING FROM THE PLUNGER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305060 BATCH NO: 0041393. IT WAS REPORTED THAT RUBBER STOPPER/PLUNGER PIECE DISLODGING UPON DRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686543 SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 305060 0041393 30382903050605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other