BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET BN311 W/O PUMP T-TYPE

    MDR report key: 9526116 · Received December 27, 2019

    Report

    Report Number
    2243072-2019-02903
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    December 10, 2019
    Report Date
    January 9, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: INVESTIGATIONS: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2807172. FROM VISUAL INSPECTION, SBDM OBSERVED TEAR ON THE COMPLAINT SAMPLE. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS OF HOUSE SAMPLES FROM LOTS 2806272, 2807172 & 2810012, NO ABNORMALITY OBSERVED. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD, NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE IS NO SIMILAR ISSUE OF THE SAME PRODUCT FROM OTHER CUSTOMER. ROOT CAUSE: FROM INVESTIGATIONS, THE TEAR SEEMED ROUGH AND NOT DUE TO A SHARP TOOL. SBDM TRIED TO FIND A PLACE THAT SAME ISSUE COULD OCCUR IN THE EXTRUDING MACHINE (WATER VESSEL, TUBE MOVING BELT AND COILING DRUM). THERE IS A CUTTING POINT ON THE COILING DRUM, AND IT IS POSSIBLE THAT THE CUTTING POINT WAS DAMAGED ON THE DRUM AND THE TUBE WAS CAUGHT IN THE SHARP POINT. THEREFORE, THE TUBE WAS DAMAGED. IN SUMMARY, THERE IS POSSIBILITY FOR THE TUBE TO BE TORN WHILE COILING ON THE DRUM. HOWEVER, THE IV SET ASSEMBLY LINE WORKER DID NOT FIND THE IV SET TUBE TORN AND IT CAUSED THIS COMPLAINT CASE. CORRECTIVE ACTIONS: 1. SBDM CONDUCTED QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR IV SET TUBE MANUFACTURING PROCESS LINE WORKERS AND QUALITY INSPECTORS. 2. SBDM STRENGTHEN INCOMING INSPECTION FOR IV SET TUBE COMPONENTS TO IMPROVE PRODUCT QUALITY. 3. SBDM IMPLEMENTED TIGHTENED PRODUCT & PROCESS MONITORING OF IV SET MANUFACTURING PROCESS. 4. SBDM MAINTAINED CUTTING POINT OF ALL DRUMS AND WILL MANAGE IT TIGHTLY. SBDM HAS IN HOUSE CAPA-19-112 IN PLACE TO MONITOR TREND. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD¿ IV SET BN311 W/O PUMP T-TYPE THE IV SET TUBE WAS TORN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV SET TUBE TORN THEY SAID "DON'T USE SCISSORS.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 · 1

    IT WAS REPORTED THAT DURING USE OF THE BD¿ IV SET BN311 W/O PUMP T-TYPE THE IV SET TUBE WAS TORN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV SET TUBE TORN THEY SAID "DON'T USE SCISSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322760 BD¿ IV SET BN311 W/O PUMP T-TYPE INTRAVASCULAR ADMINISTRATION SET FOZ BECTON DICKINSON 2807172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other