BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 10452239 · Received August 25, 2020

    Report

    Report Number
    1911916-2020-00813
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 13, 2020
    Report Date
    August 19, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 8221516. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. 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. INVESTIGATION CONCLUSION: NO SAMPLE WAS RECEIVED. THEREFORE, SAMPLE ANALYSIS COULD NOT BE PERFORMED, AND THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. HISTORY OF COMPLAINTS OF THIS LOT# WAS PERFORMED FOR THE PERIOD OF 2018 TO JULY 2020; THIS IS THE 1ST COMPLAINT FOR THIS SYMPTOM. THIS IS ALSO THE 1ST COMPLAINT FOR ANY OTHER SYMPTOM. FROM THIS OR ANY OTHER CUSTOMER. A REVIEW OF THE APPLICABLE FMEA/EURA (B)(4) INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION. ROOT CAUSE DESCRIPTION: WITH NO SAMPLE ANALYSIS WE CAN¿T OFFER A PROBABLE ROOT CAUSE. RATIONALE: BASED ON THE INVESTIGATION AND WITH NO ANALYSIS OF A SAMPLE THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THIS LOT AND SYMPTOM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE WAS NOT STERILE. THIS WAS FOUND PRIOR TO USE, AND THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECENTLY HAD STERILITY TESTING FAILURES ON OUR FINAL PRODUCT AND ARE WORKING ON INVESTIGATING THE CAUSE FOR FAILURES. ALTHOUGH WE HAVE NOT IDENTIFIED A SPECIFIC CAUSE OR MATERIAL, I AM REACHING OUT TO ALL MANUFACTURERS OF THE STERILE PRODUCTS USED IN THE PRODUCTION OF THESE BATCHES TO SEE IF THERE HAD BEEN ANY CONCERNS OR COMPLAINTS FROM OTHER CUSTOMERS REGARDING THESE PRODUCT LOT NUMBERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916679 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 8221516 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other