BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE STERILE, SINGLE USE

    MDR report key: 8387157 · Received March 4, 2019

    Report

    Report Number
    1213809-2019-00295
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    January 29, 2019
    Report Date
    April 29, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FIVE PHOTOS OF LOOSE 5ML SYRINGES WERE RECEIVED AND VISUALLY EVALUATED. IN TWO PHOTOS AN INSECURE STOPPER WAS OBSERVED. ONE PHOTO SHOWED AN OPENED BLISTER BACK FROM BATCH #8242797 (P/N 309646). TWO PHOTOS DISPLAY MULTIPLE DARK RED FOREIGN MATTER PARTICLES ON THE BARREL AND FLANGE OF THE SYRINGE. THEY APPEAR TO BE EMBEDDED WITH AT LEAST ONE LARGER THAN LEVEL THREE IN SIZE, WHICH IS CONSIDERED REJECTABLE PER PRODUCT SPECIFICATION. A PHYSICAL SAMPLE IS NEEDED TO DETERMINE WHAT THE FOREIGN MATTER IS COMPOSED OF. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE FOR THE INSECURE STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT CANNOT BE DETERMINED BASED ON PHOTOS PROVIDED, IT IS DIFFICULT TO DETERMINE IF THE DEFECT WAS CREATED AT THE MOLDING OR ASSEMBLY PROCESS WITHOUT HAVING THE ACTUAL SAMPLES TO EVALUATE OTHER ASPECTS OF THE PRODUCT THAT COULD LEAD TO A BETTER UNDERSTANDING OF THE PRODUCT DEFECT FOUND AND THE SOURCE OF THE PROBLEM. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8242797 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE ON ONE SYRINGE THE STOPPER SEPARATED FROM THE PLUNGER ROD. PARTICLES WERE DISCOVERED INSIDE THE BARREL OF ANOTHER SYRINGE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8242797. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-08-30. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE ON ONE SYRINGE THE STOPPER SEPARATED FROM THE PLUNGER ROD. PARTICLES WERE DISCOVERED INSIDE THE BARREL OF ANOTHER SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181853 BD LUER-LOK SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other