BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER SLIP TIP SYRINGE

    MDR report key: 14658936 · Received June 10, 2022

    Report

    Report Number
    1213809-2022-00329
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 23, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: ONE PHOTO DISPLAYING A 1ML SYRINGE (P/N 301025) WITH CUSTOMER ATTACHED NEEDLE WAS RECEIVED AND EVALUATED. THE SYRINGE BARREL WAS OBSERVED TO BE BOWED AND MISSING ITS PRINTED SCALE. THE OBSERVED CONDITIONS WERE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE BOWED BARREL DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. IT IS LIKELY THE PRINT WAS MISSING DUE TO THE PROCESSING OF A BOWED BARREL THROUGH THE MARKING MACHINE. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH 1061961 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1061961. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION 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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE NO SCALE MARKINGS ON THE BD¿ LUER SLIP TIP SYRINGE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AN ACCOUNT MANAGER ON BEHALF OF THE NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE SYRINGE IN THE PACK... DID NOT HAVE ANY NUMBERS LISTED FOR THE SCRUB TO KNOW HOW MUCH TO FILL. THERE WAS NO HARM TO THE PATIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE NO SCALE MARKINGS ON THE BD¿ LUER SLIP TIP SYRINGE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AN ACCOUNT MANAGER ON BEHALF OF THE NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE SYRINGE IN THE PACK... DID NOT HAVE ANY NUMBERS LISTED FOR THE SCRUB TO KNOW HOW MUCH TO FILL. THERE WAS NO HARM TO THE PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309400 BD¿ LUER SLIP TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1061961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown