BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD TUBING SET

    MDR report key: 10931810 · Received December 2, 2020

    Report

    Report Number
    2243072-2020-01974
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    October 29, 2020
    Report Date
    December 11, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-02 H6: INVESTIGATION SUMMARY CUSTOMER REPORTED TUBING CAME APART AT THE PUMPING SEGMENT AND RETURNED THE AFFECTED SAMPLE. THE SAMPLE IS CLEARLY SEPARATED AND THE COMPLAINT IS CONFIRMED. DIMENSIONAL ANALYSIS FOUND THAT THE SILICON TUBING INNER DIAMETER WAS STRETCHED TO .137 AND OUTSIDE THE TOLERANCE (.132-.129). THERE WAS A RETAINER RING INDENTATION ON THE TUBING MEANING THAT IT WAS ASSEMBLED CORRECTLY, BUT THE RETAINER RING WAS NOT RETURNED FOR THE INVESTIGATION. SINCE THERE IS A RETAINER RING, AND THE TUBING WAS SLIGHTLY STRETCHED, THE ROOT CAUSE IS DETERMINED TO BE EXCESSIVE FORCE ON THE TUBING (>3.4 LBS RETENTION FORCE). WE STRONGLY RECOMMEND CAREFULLY LOADING THE PUMP SEGMENT TOP CLIP FIRST AND THEN BOTTOM TO HELP AVOID THIS FAILURE. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL OR LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED BD TUBING SET EXPERIENCED COMPONENT SEPARATION AND AIR BUBBLES/AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN. BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE RN WAS FLICKING THE TUBING TO REMOVE AIR, AND THE TUBING CAME APART WHERE IT ATTACHES TO THE PUMP. ¿ CAN YOU DESCRIBE THE REPORTED DEFECT IN DETAIL? WHAT HAPPENED? WHAT WAS THE CAUSE? WHO WAS INVOLVED? O -LIPIDS IV TUBING KEPT BEEPING AIR IN LINE FROM 8A-12P. RN IN ROOM TO FLICK TUBING TO REMOVE AIR. TUBING CAME APART AT WHERE ATTACHES INTO PUMP. O -PHYSICIAN NOTIFIED OF PT LIPIDS BECOMING DISCONNECTED. NOTIFIED PHARMACY AND WILL TRY TO GET TPN/LIPIDS EARLIER THAN USUAL. ¿ LIPIDS STOPPED/DISCONNECTED AT 1202 ON 10/29 ¿ NEW BAG STARTED AT 1600 ON 10/29 ¿ CAN YOU PROVIDE THE DATE(S) FOR THE REPORTED FAILURE(S)? O (B)(6)2020.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD TUBING SET EXPERIENCED COMPONENT SEPARATION AND AIR BUBBLES/AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE RN WAS FLICKING THE TUBING TO REMOVE AIR, AND THE TUBING CAME APART WHERE IT ATTACHES TO THE PUMP. CAN YOU DESCRIBE THE REPORTED DEFECT IN DETAIL? WHAT HAPPENED? WHAT WAS THE CAUSE? WHO WAS INVOLVED? LIPIDS IV TUBING KEPT BEEPING AIR IN LINE FROM 8A-12P. RN IN ROOM TO FLICK TUBING TO REMOVE AIR. TUBING CAME APART AT WHERE ATTACHES INTO PUMP. PHYSICIAN NOTIFIED OF PT LIPIDS BECOMING DISCONNECTED. NOTIFIED PHARMACY AND WILL TRY TO GET TPN/LIPIDS EARLIER THAN USUAL. LIPIDS STOPPED/DISCONNECTED AT 1202 ON (B)(6). NEW BAG STARTED AT 1600 ON (B)(6). CAN YOU PROVIDE THE DATE(S) FOR THE REPORTED FAILURE(S)? (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398964 UNSPECIFIED BD TUBING SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR