BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GRAVITY SET

    MDR report key: 18728357 · Received February 17, 2024

    Report

    Report Number
    9616066-2024-00258
    Event Type
    Malfunction
    Date Received
    February 17, 2024
    Date of Event
    December 22, 2023
    Report Date
    May 29, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CONTAMINATION. ONE PHOTO WAS RECEIVED FOR QUALITY EVALUATION. REVIEW OF THE PHOTO SUBMITTED, SHOWS THAT THERE IS A UNIDENTIFIED PARTICLE INSIDE OF THE DRIP CHAMBER. THE CUSTOMER COMPLAINT OF FOREIGN MATTER WAS CONFIRMED. DUE TO NO PHYSICAL SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THE FAILURE WAS REPORTED TO THE MANUFACTURING LOCATION OF THE DRIP CHAMBER FOR AWARENESS OF THE ISSUE. A DEVICE HISTORY RECORD REVIEW FOR MODEL DYNDTN1545 LOT NUMBER 23065159 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 07JUN2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BD GRAVITY SET HAD FOREIGN MATTER IN THE FLUID PATHWAY THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: MEDLINE HAS REPORTED ANOTHER ISSUE FOR THE DYNDTN1545 SET. FORMAL COMPLAINT FORM IS ATTACHED AND BELOW ARE THE DETAILS AND PICTURES. (B)(6): LINE 10 DYNDTN1545 - PER TONY MOK TIN STONE FOUND INSIDE THE TUBE OF IV TUBING 15 DROP.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#:200594732 BATCH#:23065159. IT WAS REPORTED BY THE CUSTOMER THAT DYNDTN1545 CONTAMINATION. VERBATIM: CASE IS MANUALLY CREATED SINCE THE MANUAL ENTRY NEEDED BASED ON THE DAILY INTAKE REPORT 01FEB2024 (ERROR TRACKING TAB). RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. MEDLINE HAS REPORTED ANOTHER ISSUE FOR THE DYNDTN1545 SET. FORMAL COMPLAINT FORM IS ATTACHED AND BELOW ARE THE DETAILS AND PICTURES. (B)(4): LINE 10 DYNDTN1545 - PER (B)(6) TIN STONE FOUND INSIDE THE TUBE OF IV TUBING 15 DROP. LOT 23065159; EXP 60-67-2026. ADDITIONAL COMMENTS: MFGRG PLANT: BD TIJUANA MEXICO. QUALITY CONTACTS: (B)(6) (IN COPY). PLEASE COMMUNICATE WITH (B)(6) AS THEY ARE THE PLANT QUALITY INVESTIGATORS . SAMPLES CAN BE PROVIDED, AND YOU WILL NEED TO CONTACT THE CUSTOMER FOR THE DETAILS. NOTE: SAMPLES NEEDS TO BE SENT DIRECTLY TO BD TIJUANA, MEXICO TO (B)(6) ATTENTION. COMMENTS ON 05/02/2024, 1. PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? A. THERE IS NO SAMPLE AVAILABLE FOR RETURN OF THIS COMPLAINT ONLY A PHOTO (ATTACHED). 2. PLEASE PROVIDE THE DATE OF EVENT. 12/22/2023. 3. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? THE EVENT INVOLVED THE CLINICIAN BEFORE USING THE PRODUCT. 4. DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? THIS DID NOT REQUIRE/INVOLVE URGENT OR A LIFE THREATENING MEDICAL SITUATION. COMMENTS ON 20/03/2024. THE SAMPLE FOR (B)(4) IS HERE IN VERNON HILLS. TESTING WAS CONDUCTED AND THE FAILURE REPORTED COULD NOT BE VERIFIED. ALTHOUGH THERE IS A KINK IN THE TUBING, THE INFUSION SET ALLOWS FOR GOOD FLUID FLOW. THE FAILURE OF OCCLUSION COULD NOT BE VERIFIED. PLEASE LET ME KNOW IF YOU WOULD LIKE FOR ME TO FORWARD THE SAMPLES. WE HAVE YET TO RECEIVE A SAMPLE FOR (B)(4). IT LOOKS AS IF A SHIPPING LABEL HAD NOT BEEN PROVIDED TO THE CUSTOMER FOR THE PHYSICAL SAMPLE. I HAVE REQUESTED THE RCC TEAM TO PROVIDE A SHIPPING LABEL FOR THAT SAMPLE. FOR PR (B)(4) WE HAVE NOT RECEIVED A PHYSICAL SAMPLE, HOWEVER, THE CUSTOMER HAS PROVIDED A PHOTO. WE CAN CONFIRM THAT THERE APPEARS TO BE FOREIGN MATTER ON THE DRIP CHAMBER BASED ON THE PHOTO, HOWEVER, WE WILL MOST LIKELY NOT BE ABLE TO FORWARD THE INVESTIGATION TO THE SUPPLIER BECAUSE OF THE LACK OF A PHYSICAL SAMPLE. I WILL FORWARD THE INFORMATION TO THE SQE TEAM AND SEE IF THE SUPPLIER WILL STILL CONDUCT AN INVESTIGATION WITH ONLY A PHOTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432859 BD GRAVITY SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23065159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown