BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 12147372 · Received July 9, 2021

    Report

    Report Number
    1213809-2021-00487
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 10, 2021
    Report Date
    June 23, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: TWO PHOTOS SHOWING A 10ML SYRINGE (MATERIAL 302995) AND A BLISTERPAK FROM BATCH 1082947 WERE RECEIVED AND EVALUATED. THE SYRINGE WAS CAPPED OUTSIDE OF CANAAN'S MANUFACTURING PROCESS AND WAS FILLED WITH AN UNKNOWN LIQUID. NEAR THE 8ML GRAD LINE A PIECE OF FOREIGN MATTER WAS PRESENT IN THE FLUID PATH. THE FOREIGN MATTER APPEARED TO BE A PIECE OF WOOD. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 1082947 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. 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. INVESTIGATION CONCLUSION: POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE AQL FOR FOREIGN MATTER IS 0.65%. THE DEFECTIVE RATE IDENTIFIED IS 1 OUT OF 504,000 WHICH IS 0.0002%. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH #1082947 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DRAWING UP THE METHOHEXITAL SYRINGES A WOOD SPLINTER APPEARED. WE DIDN'T THINK IT WAS FROM THE VIAL AS THE REMAINING SOLUTION WAS CLEAR AND I DOUBT THAT WOULD PASS THRU THE SYRINGE NEEDLE. WE ARE THINKING IT WAS IN THE 10ML SYRINGE AND THAT THOSE COULD BE COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038358 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 1082947 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1