BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE

    MDR report key: 11325282 · Received February 12, 2021

    Report

    Report Number
    1213809-2021-00081
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    January 20, 2021
    Report Date
    February 2, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. BASED ON THE VERBATIM, THE MIXED PRODUCT WAS REPORTED TO HAVE A DIFFERENT TIP CONFIGURATION WHERE THE COLLAR WAS NOT PRESENT. THE ONLY POTENTIAL EVIDENCE PROVIDED WAS THE PHOTO LABELED "10450". TAKING THE SYRINGE IN THE PHOTO INTO ACCOUNT, THE PRINTED SCALE ON THE BARREL DOES NOT MATCH ANY PRODUCT THAT WAS MANUFACTURED DURING THE TIME OF THE REPORTED BATCH 0153258. THEREFORE, THE MIXED PRODUCT DEFECT COULD NOT BE CONFIRMED. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR SYRINGES FROM MATERIAL# 303127 WERE FOUND IN THE BATCH OF 75 BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING OUR PRODUCTION WE FOUND A MIX OF SYRINGES IN PRODUCT 301027, LOT 0153258. WE FOUND (B)(4) SYRINGES OF MATERIAL 303127 IN OUR PRODUCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221606 BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0153258

    Patients

    Seq Age Sex Outcome Treatment
    1