BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE

    MDR report key: 17413701 · Received July 28, 2023

    Report

    Report Number
    1911916-2023-00529
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    June 26, 2023
    Report Date
    July 10, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE WAS OBSERVED TO HAVE RESIDUE INSIDE THE CYLINDER. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE SYRINGE BARREL HAS RESIDUES OF A YELLOWISH COLORED DRUG. THE RUBBER STOPPER HAS A VISIBLE DROPLET OF LUBRICANT APPLIED TO IT WHICH IS CONSIDERED AN ACCEPTABLE IMPERFECTION. THE LUBRICANT IS MEDICAL GRADE AND APPLIED TO THE SYRINGE RUBBER STOPPER AND THE INNER WALL OF THE SYRINGE BARREL. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 2243831. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD LUER-LOK¿ SYRINGE STERILE THERE WAS RESIDUE INSIDE THE CYLINDER. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER: VERBATIM : DETAILS OF ISSUE: SYRINGE WAS OBSERVED TO HAVE RESIDUE INSIDE THE CYLINDER. WE DISCARDED A VIAL OF MEDICATION WHILE COMPOUNDING DUE TO CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919948 BD LUER-LOK¿ SYRINGE STERILE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2243831 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown