BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 12185927 · Received July 16, 2021

    Report

    Report Number
    1213809-2021-00495
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 17, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096053
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. INVESTIGATION SUMMARY: ONE LOOSE 10ML SYRINGE FILLED WITH MEDICATION (P/N 309605) AND CUSTOMER ATTACHED TIP CAP WAS RECEIVED. DUE TO POTENTIAL RISK INVOLVED WITH DIRECT SAMPLE HANDLING, THE SAMPLE WAS EVALUATED THROUGH THE BAG ONLY. A LARGE STRAND OF FOREIGN MATTER COULD BE SEEN FLOATING IN THE FLUID PATH. THE FOREIGN MATTER APPEARED TO BE A PIECE OF PLASTIC AND WAS NON-CONFORMING PER PRODUCT SPECIFICATION. BATCH #1081418 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT OR BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A PIECE OF PLASTIC WAS FOUND WITHIN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082126 SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1081418 00382903096053

    Patients

    Seq Age Sex Outcome Treatment
    1