BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 10022751 · Received May 4, 2020

    Report

    Report Number
    1213809-2020-00285
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 11, 2020
    Report Date
    June 4, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097020
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9120503. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, A LARGE BLACK SMEAR MARK WAS OBSERVED ON THE OUTSIDE OF THE BARREL NEAR THE 1ML MARKING. THE SMEAR APPEARS TO BE AN INK MARK. IT HAS BEEN DETERMINED THAT THIS INCIDENT WAS A RESULT OF AN ERROR IN THE SCALE MARKING PROCESS. BASED ON THE INVESTIGATION CONCLUSION, THE REPORTED DEFECTS ARE NOT RELATED WITH OUR PACKAGING PROCESS. THEREFORE, ROOT CAUSE CANNOT BE DETERMINED. DUE TO THE LOW OCCURRENCE OF THIS DEFECT, FURTHER CORRECTIVE ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS NOTICED INSIDE THE BD LUER-LOK¿ SYRINGE DURING USE AFTER IT HAD BEEN FILLED WITH NARCOTIC SOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPON ATTACHING A NEW 3ML SYRINGE FROM A BULK STERILE PACK TO A COLLECTOR BAG, THE PHARMACY TECHNICIAN NOTICED THERE WAS DEBRIS WITHIN THE BARREL OF THE SYRINGE AFTER THE SYRINGE HAD BEEN FILLED WITH DRUG SOLUTION. THIS SYRINGE COULD NOT BE USED AS THE DEBRIS COMPROMISED THE STERILITY OF THE PREPARATION. THIS SYRINGE AND ITS CONTENTS WERE DESTROYED. THE PREPARATION WAS A NARCOTIC MEDICATION THEREFORE THE SYRINGE AND ITS CONTENTS HAD TO BE DESTROYED AND CANNOT BE SENT TO THE MANUFACTURER."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS NOTICED INSIDE THE BD LUER-LOK¿ SYRINGE DURING USE AFTER IT HAD BEEN FILLED WITH NARCOTIC SOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPON ATTACHING A NEW 3ML SYRINGE FROM A BULK STERILE PACK TO A COLLECTOR BAG, THE PHARMACY TECHNICIAN NOTICED THERE WAS DEBRIS WITHIN THE BARREL OF THE SYRINGE AFTER THE SYRINGE HAD BEEN FILLED WITH DRUG SOLUTION. THIS SYRINGE COULD NOT BE USED AS THE DEBRIS COMPROMISED THE STERILITY OF THE PREPARATION. THIS SYRINGE AND ITS CONTENTS WERE DESTROYED. THE PREPARATION WAS A NARCOTIC MEDICATION THEREFORE THE SYRINGE AND ITS CONTENTS HAD TO BE DESTROYED AND CANNOT BE SENT TO THE MANUFACTURER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483737 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309702 9120503 30382903097020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other