BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ 1-ML SYRINGE

    MDR report key: 16579878 · Received March 20, 2023

    Report

    Report Number
    1213809-2023-00230
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    March 1, 2023
    Report Date
    April 10, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 23-MAR 2023. H6: INVESTIGATION SUMMARY: ONE SAMPLE AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE SAMPLE HAS TWO LINES EXTENDING DOWN THE BARREL IN THE SCALE MARKING AREA. THE FIRST LINE EXTENDS FROM 0.1ML GRAD LINE TO 0.7ML GRAD LINE AND HAS A DARK WHITE DISCOLORATION AT THE 0.1ML GRAD LINE AREA. THE SECOND LINE STARTING AT THE 0.7ML GRAD LINE EXTENDING DOWN TO THE FLANGE WITH A BLACKISH SMOKY DISCOLORATION. THE OBSERVED BARREL CRACK LINE IS MOST LIKELY EMBEDDED FOREIGN MATTER. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THIS DEFECT OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 9142579. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ 1-ML SYRINGE THE BARREL WAS CRACKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER REPORTER, THE SUPPLIED SYRINGE HAD A CRACK ALONG THE BODY OF IT THAT WAS NOTICED AFTER THE MEDICATION WAS DRAWN UP INTO THE SYRINGE. SYRINGE DID NOT LEAK MEDICATION HOWEVER PHYSICIAN OPTED TO NOT ADMINISTER MEDICATION DUE TO THE DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ 1-ML SYRINGE THE BARREL WAS CRACKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER REPORTER, THE SUPPLIED SYRINGE HAD A CRACK ALONG THE BODY OF IT THAT WAS NOTICED AFTER THE MEDICATION WAS DRAWN UP INTO THE SYRINGE. SYRINGE DID NOT LEAK MEDICATION HOWEVER PHYSICIAN OPTED TO NOT ADMINISTER MEDICATION DUE TO THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370863 BD LUER-LOK¿ 1-ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9142579 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown