BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN122 W/O PUMP T-TYPE

    MDR report key: 8723038 · Received June 21, 2019

    Report

    Report Number
    2243072-2019-01234
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 28, 2019
    Report Date
    July 11, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    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: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2903152. FROM VISUAL INSPECTION OF THE FM, IT LOOKS LIKE A PIECE OF RUBBER. INFRARED SPECTROMETRY (IR) ANALYSIS: FROM IR ANALYSIS OF THE FM, IT WAS DETERMINE TO BE SAME COMPONENT WITH RAW MATERIAL OF RUBBER TUBE (LATEX GLOVES) HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS HOUSE SAMPLES FROM LOTS 2903112, 2903152, 2903222, NO ABNORMALITY OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 2903152 NO ABNORMALITY WAS OBSERVED. ROOT CAUSE: FROM INVESTIGATIONS, THE RUBBER TUBE IS SUPPLIED BY OUTSOURCE. SBDM ISSUED CAPA-19-075 TO FIND OUT THE ROOT CAUSE OF THE COMPLAINT CASE. ACCORDING TO THE SUPPLIER, THE RUBBER TUBE COMPONENTS ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE. AT THAT TIME, BURR WAS FORMED AND NOT CLEARED IN CLEANING PROCESS. SUBSQUENTLY, I.V SET ASSEMBLY LINE WORKERS COULD NOT FIND THE FM DUE TO THE FM MIGHT BE INSIDE OF THE RUBBER TUBE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE IV SET AN122 W/O PUMP T-TYPE THERE WAS FOREIGN MATTER FLOATING IN THE IV LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER IN IV SET FLOATING IN IV LINE

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. 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 IV SET AN122 W/O PUMP T-TYPE THERE WAS FOREIGN MATTER FLOATING IN THE IV LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER IN IV SET FLOATING IN IV LINE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515238 IV SET AN122 W/O PUMP T-TYPE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 2903152

    Patients

    Seq Age Sex Outcome Treatment
    1 Other