BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL TIP CONV PAK

    MDR report key: 18581530 · Received January 25, 2024

    Report

    Report Number
    9610847-2024-00008
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    January 5, 2024
    Report Date
    February 5, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903056171
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE ONE SAMPLE AND THREE PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE SAMPLE AND PHOTOS. ANALYSIS OF THE SAMPLE AND PHOTOS SHOWED THAT A STRING OF PLASTIC WAS ADHERED TO THE SYRINGE PLUNGER ROD. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS RELATED TO OUR MANUFACTURING PROCESS. THE MANUFACTURING ASSOCIATES FOR THIS PRODUCT WILL BE SHOWN THE SAMPLE FOR AWARENESS. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY.

    Additional Manufacturer Narrative · 0

    H.3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIALS#: 305617, BATCH#: 3150617. IT WAS REPORTED BY THE CUSTOMER THAT A CONTAMINANT NOTED IN SYRINGE. RCC RECEIVED A COMPLAINT VIA EMAIL. REQUESTING AN RGA TO RETRIEVE THE CARTON AND RECEIVE A CREDIT. RESPONSE RECEIVED. 1. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN. 09/15/2023: HUTCHINS RECEIVED PRODUCT FROM SUPPLIER (B)(4). 11/22/2023: HUTCHINS SHIPPED PRODUCT TO CUSTOMER (LARGE QUANTITY VIA PALLET). ON (B)(6) 2024: CUSTOMER REPORTED CONTAMINANT (PLASTIC?) INSIDE SYRINGE. 2. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? NO PATIENT OR HEALTH CONSEQUENCE REPORTED BY OUR CUSTOMER 3. ANY PHYSICAL SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? PLEASE EMAIL RETURN SHIPPING LABEL TO ME AT THIS EMAIL ADDRESS CUSTOMER ADDRESS: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD SYRINGE 20ML LL TIP CONV PAK HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT A CONTAMINANT NOTED IN SYRINGE . VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PLEASE SEE THE ATTACHED PICTURES FOR A CONTAMINANT NOTED IN SYRINGE 305617, LOT 3150617. REQUESTING AN RGA TO RETRIEVE THE CARTON AND RECEIVE A CREDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954214 BD SYRINGE 20ML LL TIP CONV PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3150617 30382903056171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown