BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 11508069 · Received March 17, 2021

    Report

    Report Number
    1911916-2021-00214
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 18, 2021
    Report Date
    March 11, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN:  (B)(6). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 9182721. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. BOTH PHOTOS SHOW A MAGNIFICATION OF FOREIGN MATTER. THERE IS A PLASTIC RULER AND A NOTE THAT THE FOREIGN MATTER IS BETWEEN 25 TO 35MM LONG. THE CUSTOMER STATES THAT IT IS TEXTILE AND WAS FOUND IN THEIR PROCESSES WITH AN UNKNOWN ORIGIN. IT APPEARS TO BE A DARK COLOR FIBER. BASED ON THE PHOTO PROVIDED WE DO NOT KNOW THE SOURCE OF THE TEXTILE DETECTED IN THE CUSTOMER'S PROCESSES. WE DO NOT USE TEXTILE MATERIALS IN OUR MANUFACTURING PROCESSES. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THIS PRODUCT AND SYMPTOM. WITH NO SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. BASE ON THE PHOTO PROVIDED WE DO NOT KNOW THE SOURCE OF THE TEXTILE FIBER DETECTED IN THE CUSTOMER PROCESS. WE DO NOT USE TEXTILE MATERIALS IN OUR PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD 60ML SYRINGE LUER-LOK¿ TIP EXPERIENCED FOREIGN MATTER IN SYRINGE OR ANY FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309653, BATCH NO: 9182721. ONE OF OUR INTERNAL MANUFACTURING SITES IS COMPLETING AN INVESTIGATION INTO FOREIGN MATERIAL FOUND IN THE PROCESS, THE MATERIAL WAS A TEXTILE FIBER. A REQUEST TO PROVIDE DOCUMENTATION REGARDING ANY SIMILAR EVENTS FOR THE FOLLOWING MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404674 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9182721

    Patients

    Seq Age Sex Outcome Treatment
    1