BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7152813 · Received December 28, 2017

    Report

    Report Number
    1213809-2017-00404
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    December 5, 2017
    Report Date
    January 29, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: DHR: MANUFACTURING DATES: 02/04/2017 TO 02/05/2017. LOT QUANTITY WAS 302,400. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. 200 PACKAGED 1ML SYRINGES WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM LOT #7030524. THE SAMPLE WAS VISUALLY EVALUATED. THE PACKAGES WERE FOUND TO HAVE THE BATCH NUMBER AND EXPIRATION DATE MISSING FROM THE TOP WEB. INVESTIGATION CONCLUSION: CONFIRMED: BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. MOST PROBABLE ROOT CAUSE IS THAT THE PRINTER WAS SHUT OFF WHILE TROUBLESHOOTING THE MACHINE AFTER ADJUSTMENTS AND MANUALLY INDEXING THE SHOTS OF PRODUCT. THE AFFECTED PRODUCT WAS THEN NOT PROPERLY DISCARDED.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED BD LUER-LOK¿ DISPOSABLE SYRINGE(S) WITHOUT LOT NUMBERS AND EXPIRATION DATES. THEY ALSO RECEIVED SOME DEFECTIVE SYRINGES. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929519 BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7030524 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other