BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK¿ 5ML SYRINGE

    MDR report key: 7004319 · Received November 6, 2017

    Report

    Report Number
    1213809-2017-00246
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 12, 2017
    Report Date
    January 26, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903055587
    PMA / PMN Number
    K944757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED (25) TWENTY FIVE PACKAGED 5ML SAFETY LOK SYRINGES, SOME APPEARED OPENED BY CUSTOMER. THE SAMPLES WERE CONFIRMED TO BE FROM BATCH #1203588. THE SAMPLES WERE VISUALLY EVALUATED. NOTE: THIS BATCH HAS EXPIRED. THE SYRINGES WERE FOUND TO HAVE AN OVER LABEL ATTACHED TO THE TOP WEB ON ONE SIDE. THE LABEL DOES NOT HAVE THE ¿LATEX FREE¿ STATEMENT THAT THE ORIGINAL TOP WEB HAS. REGARDING THE GRAPHICS ON THE ORIGINAL TOP WEB ¿ THE PRODUCT WAS INSPECTED, ACCEPTED AND RELEASED WITH THE ORIGINAL TOP WEB GRAPHICS. ALL INFORMATION INCLUDED IN THE ORIGINAL TOP WEB WAS ACCURATE AND CORRECT AT THE TIME THE PRODUCT WAS RELEASED TO MARKET. THE OVER LABELING DID NOT AFFECT THE ACCURACY OF THE ORIGINAL INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER. CONCLUSION: BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE, HOWEVER IT WAS NOT A DEFECT. CORRECTION: LOT # : 1203588. DEVICE MANUFACTURE DATE: 09/02/2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SAFETY-LOK¿ 5ML SYRINGE HAD TWO LABELS ON EACH PACKAGE. ONE STATES ¿LATEX FREE¿ WHILE THE OTHER DOESN¿T. 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
    784185 BD SAFETY-LOK¿ 5ML SYRINGE SYRINGE FMI BECTON DICKINSON MEDICAL SYSTEMS 1203588 30382903055587

    Patients

    Seq Age Sex Outcome Treatment
    1 Other