BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50CC LL TIP CONVENIENCE PAK

    MDR report key: 20208265 · Received September 12, 2024

    Report

    Report Number
    9610847-2024-00257
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 19, 2024
    Report Date
    January 16, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903096800
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 5 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. UNFORTUNATELY, WE ARE UNABLE TO LOCATE THE RETURNED SAMPLE AT THIS TIME. THIS IS A RARE OCCURRENCE, AND WE DO APOLOGIZE. SHOULD WE LOCATE THE SAMPLE, WE WILL RE-INVESTIGATE AND RESPOND BACK WITH THE RESULTS. 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. 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.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. OTHER LOT NUMBER INCLUDE 2355377, 2355372 AND 2334770. 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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL: 309680, BATCH#: 2355377; 2355372; 2334770; 2355365. IT WAS REPORTED BY THE CUSTOMER THAT HAS DETECTED AN INCREASE IN COSMETIC DEFECTS DUE TO ¿STATIONARY WHITE PARTICLES ON PLUNGER¿ AND ARE CONTRIBUTING TO EXCEEDING INTERNAL ACTION LIMITS FOR OVERALL DEFECTS DURING LEITERS IN-PROCESS VISUAL INSPECTION OF FILLED SYRINGES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. HAS DETECTED AN INCREASE IN COSMETIC DEFECTS DUE TO ¿STATIONARY WHITE PARTICLES ON PLUNGER¿ AND ARE CONTRIBUTING TO EXCEEDING INTERNAL ACTION LIMITS FOR OVERALL DEFECTS DURING LEITERS IN-PROCESS VISUAL INSPECTION OF FILLED SYRINGES. ITEM NUMBER # 309680. LOT NUMBER - 2355377; 2355372; 2334770; 2355365. CUSTOMER RESPONSE: 1. KINDLY PROVIDE THE DATE OF EVENT FOR ALL BATCH NUMBERS. LEITERS BATCH # 2430695 WAS VISUALLY INSPECTED ON 22JUL2024 AND YIELDED AN OVERALL DEFECT LIMIT OF 11% WHICH EXCEEDED THE INTERNAL ACTION LIMIT OF 10%. OF THE 331 SYRINGE UNITS THAT WERE CULLED FROM THE BATCH DUE TO OBSERVED DEFECTS, 191 OF THESE (I.E., 58%) WERE DUE TO COSMETIC DEFECTS (E.G., ¿WHITE DOTS ON THE PLUNGER). 2. CAN YOU SHARE ANY PHYSICAL SAMPLE IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES, 10 COSMETIC REJECT SAMPLES ARE AVAILABLE, HOWEVER WE'RE UNABLE TO DETERMINE WHICH BD LOT # CORRESPONDS TO EACH SYRINGE DUE TO 4 BD SYRINGE LOTS WERE UTILIZED ON LEITERS BATCH # 2430695. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ADVERSE EVENTS HAVE BEEN REPORTED TO LEITERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563094 BD SYRINGE 50CC LL TIP CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2355365 00382903096800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown