BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE ONLY

    MDR report key: 17417818 · Received July 28, 2023

    Report

    Report Number
    1911916-2023-00530
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    July 3, 2023
    Report Date
    July 12, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028320
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS A PRINT ERROR. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SCALE MARKING IS SKEWED AND INCOMPLETE. IN THE THREE PHOTOS PROVIDED, ONE PHOTO SHOWS A DOCUMENT, AND THE OTHER TWO PHOTOS SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SCALE MARKING DEFECT COULD OCCUR IF THERE IS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4) , LOT 2243839. 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. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ TIP SYRINGE ONLY THERE WERE SCALE MARKING ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRINT ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921136 BD LUER-LOK¿ TIP SYRINGE ONLY PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2243839 00382903028320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown