BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK

    MDR report key: 9365489 · Received November 22, 2019

    Report

    Report Number
    9610847-2019-00697
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    November 5, 2019
    Report Date
    January 27, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097013
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE CONVENIENCE TRAY OF TWENTY-FIVE SYRINGES WAS PROVIDED FOR INVESTIGATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE RETURNED SAMPLE, FOREIGN MATTER WAS IDENTIFIED WITHIN THE TRAY. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS PERFORMED ON THE FOREIGN MATTER. THE FTIR ANALYSIS RESULTS INDICATED THAT THE FOREIGN MATTER WAS INK. AS THE CONVENIENCE TRAY LIDS ARE PRINTED, THEY MOVE DOWN A CONVEYOR. INK RESIDUE WAS FOUND TO ACCUMULATE AT THE END OF THE PRINTING MACHINE'S CONVEYOR. INK RESIDUE WAS FOUND TO ACCUMULATE AT THE END OF THE PRINTING MACHINE'S CONVEYOR. WHEN THE LID INVOLVED IN THIS INCIDENT CAME INTO CONTACT WITH THE END OF THE CONVEYOR, IT BECAME CONTAMINATED WITH INK RESIDUE. THIS DEFECT WAS UNDETECTED DURING THE PRODUCTION PROCESS OF LOT NUMBER: 9213387, AS ALL INSPECTED PRODUCT WAS FOUND TO BE WITHIN SPECIFICATION. A PREVENTIVE MAINTENANCE PLAN HAS BEEN INITIATED TO PREVENT THIS DEFECT FROM RECURRING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED IN STERILE SYRINGE TRAY WITH A BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A FOREIGN SUBSTANCE WAS FOUND IN ONE OF THE CUSTOMERS STERILE SYRINGES TRAYS.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED IN STERILE SYRINGE TRAY WITH A BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A FOREIGN SUBSTANCE WAS FOUND IN ONE OF THE CUSTOMERS STERILE SYRINGES TRAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160933 BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 309701 9213387 30382903097013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other