BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 17686237 · Received September 5, 2023

    Report

    Report Number
    1213809-2023-00965
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 16, 2023
    Report Date
    January 22, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THERE IS MOLD ON THE SYRINGE. TO AID IN THE INVESTIGATION, ONE 10ML SYRINGE IN AN OPENED PACKAGING BLISTER FROM LOT 3142093 WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THERE WERE LARGE CHUNKS OF BLACK AND GREY CLAY-LIKE FOREIGN MATTER PRESENT ON THE BARREL EXTERIOR. ONE CHUNK EXTENDING FROM THE ROOF ABOUT A THIRD OF THE WAY UP THE GRADUATION SCALE, ANOTHER LARGE CHUNK ON ONE FLANGE AND AN ADDITIONAL CHUNK ABOUT HALFWAY UP THE BARREL. THE FOREIGN MATTER APPEARED TO HAVE COME OFF IN THE PACKAGING AS WELL. FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS PERFORMED AND SHOWED THE MATERIAL TO BE PRIMARILY MADE UP OF SILICONE LUBRICANT. THE OBSERVED CONDITION WAS NON-CONFORMING PER PRODUCT SPECIFICATION AND ASSOCIATED WITH THE ASSEMBLY PROCESS. THE FOREIGN MATTER IDENTIFIED IS LIKELY MADE-UP SILICONE FROM THE ASSEMBLY PROCESS WHICH IS USED AS A LUBRICANT FOR THE INNER BARREL WALL. THE CLUMPS ARE LIKELY A BUILDUP OF THE SILICONE AND OTHER DUST OR PLASTIC PARTICULATES WHICH ACCUMULATED DURING PROCESSING. THE BARREL LIKELY INADVERTENTLY ENCOUNTERED THIS MATERIAL DURING PROCESSING RESULTING IN THE CONDITION OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4), LOT 3142093. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 3142093 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ADDITIONALLY, A MACHINE EVALUATION WAS PERFORMED ALONG WITH A MAINTENANCE TECHNICIAN INTERVIEW AS PART OF THIS INVESTIGATION. IT WAS NOTED THAT THIS TYPE OF BUILDUP CAN OCCUR DURING GENERAL PROCESSING ON THE FIRST INFEED DIAL AND ON THE SILICONE DIAL. BD ENSURES THAT PROPER HOUSEKEEPING IS MAINTAINED AND PERFORMED DURING BATCH PRODUCTION VIA REQUIREMENTS IN OUR LOCAL WORK INSTRUCTIONS AND DEVICE HISTORY RECORD REQUIREMENTS. THESE AREAS ARE CLEANED EVERY SHIFT; HOWEVER, IT WAS NOTED THAT IF PRODUCT IS NOT CLEARED OUT PRIOR TO CLEANING THEN THE DEBRIS MAY INADVERTENTLY ENCOUNTER PRODUCT THAT IS IN THE MACHINE TO BE PROCESSED. A QUALITY ALERT COMMUNICATING THE SEVERITY OF THIS DEFECT AND IMPORTANCE OF REMOVING PRODUCT FROM APPLICABLE AREAS OF THE MACHINE TO BE CLEANED WAS SENT OUT TO THE MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED MAT#: (B)(4) BATCH#: 3142093 IT WAS REPORTED BY CUSTOMER THAT MOLD ON THE SYRINGE (CUSTOMER DID NOTICED SOME MOISTURE ON THE BACK OF THE PACKAGING). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED CUSTOMER REPORTED AS FOLLOW; INJURIES OR ADVERSE EVENT: NO ITEM: 302995 QUANTITY AFFECTED: 1 EA SERIAL/LOT NUMBER: (B)(6) PO : (B)(4) ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: MOLD ON THE SYRINGE (I DID NOTICED SOME MOISTURE ON THE BACK OF THE PACKAGING) CUSTOMER DISPOSITION REQUEST: REPLACEMENT (B)(6) 2023 - DATE OF EVENT: 8/16 - WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED? ONCE OPENED - WAS THERE ANY PATIENT INVOLVEMENT? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE HAD MOLD PRESENT. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: INJURIES OR ADVERSE EVENT: NO REPORTED ISSUE: MOLD ON THE SYRINGE (I DID NOTICED SOME MOISTURE ON THE BACK OF THE PACKAGING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006588 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3142093 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown