BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 9081920 · Received September 18, 2019

    Report

    Report Number
    9610847-2019-00572
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 28, 2019
    Report Date
    October 29, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9060739 & 9091835 OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN EITHER PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THESE LOTS WERE ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. THE FOREIGN MATERIAL PRESENT IN THE SUBMITTED PHOTOS WAS POSITIVELY IDENTIFIED AS CARDBOARD BUT WAS NOT PRESENT IN THE SUBMITTED DEVICES. THIS EXTRANEOUS CARDBOARD IS THE RESULT OF PERSONNEL NOT FOLLOWING THE LOADING PROCEDURE FOR RAW MATERIALS. RAW MATERIALS ARRIVE FROM OUR SUPPLIER IN DOUBLE BAGGED CONTAINERS, THE PURPOSE OF THE SECOND BAG IS TO PREVENT REMNANTS OF CARDBOARD FROM TRANSFERRING INTO THE PRODUCT HOPPER BY LEAVING ONE BAG BEHIND TO OBSTRUCT THE MATERIAL DURING LOADING. FAILURE TO FOLLOW THIS PROCEDURE CAN LEAD TO THE ACCUMULATION AND TRANSFER OF THE CARDBOARD INTO THE PRODUCTION TRAY. TO ADDRESS THIS ISSUE WE HAVE RETRAINED OUR STAFF ON THE RELEVANT POLICIES AND PROCEDURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HAD FOREIGN MATTER IN IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309680. BATCH NO. 9060739 AND 9091835. IT WAS REPORTED THAT PARTICULATES, FOREIGN MATTER, AND FIBERS FOUND IN 10 TRAYS. SYRINGE (STERILE), 60ML LL, BD TRAY 309680 (20/TRAY; 6 TRAY/CS). PARTICULATES, FOREIGN MATTER, AND FIBERS FOUND IN 10 TRAYS. FOUND (B)(6) 2019. 43 COMPOUNDED UNITS AFFECTED.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9060739; MEDICAL DEVICE EXPIRATION DATE: 2024-02-29 ; DEVICE MANUFACTURE DATE: 2019-05-28. MEDICAL DEVICE LOT #: 9091835; MEDICAL DEVICE EXPIRATION DATE: 2024-03-31; DEVICE MANUFACTURE DATE: 2019-05-03. 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 · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HAD FOREIGN MATTER IN IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309680 , BATCH NO. 9060739 AND 9091835. IT WAS REPORTED THAT PARTICULATES, FOREIGN MATTER, AND FIBERS FOUND IN 10 TRAYS. SYRINGE (STERILE), 60ML LL, BD TRAY 309680 (20/TRAY; 6 TRAY/CS) PARTICULATES, FOREIGN MATTER, AND FIBERS FOUND IN 10 TRAYS. FOUND (B)(6) 2019. 43 COMPOUNDED UNITS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878910 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other