BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH PLUS I.V. CATHETER 22GA X 1.00IN

    MDR report key: 11721171 · Received April 23, 2021

    Report

    Report Number
    8041187-2021-00348
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 29, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO PHOTOS AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. NO FOREIGN MATTER COULD BE OBSERVED FROM THE RETURNED PHOTOS AS THEY WERE UNCLEAR. ONE SAMPLE WITHOUT PACKAGING WAS RECEIVED FOR INVESTIGATION. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION TO CHECK FOR FOREIGN MATTER. ONE LOOSE BLACK THREAD-LIKE FOREIGN MATTER WAS OBSERVED ON THE SURFACE OF THE CATHETER TUBING. THE LOOSE BLACK THREAD-LIKE FOREIGN MATTER WAS SENT FOR FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING TO DETERMINE THE FOREIGN MATTER TYPE. THE RESULTS INDICATE THAT THE SPECTRUM REASONABLY MATCHES WITH THAT OF POLY(ETHYLENE TEREPHALATE). POLY(ETHYLENE TEREPHALATE) (PET) IS A THERMOPLASTIC POLYMER RESIN OF THE POLYESTER FAMILY AND IS USED IN SYNTHETIC FIBERS, CONTAINERS, THERMOFORMING IN MANUFACTURING, ENGINEERING RESINS, AND PACKAGING MATERIALS. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE MANUFACTURING PROCESS WAS REVIEWED AND THERE IS NO BLACK PET-BASED MATERIAL USED IN THE MANUFACTURING PROCESS. ALSO, THE MANUFACTURING PROCESS IS AUTOMATED, WITH MINIMAL HUMAN INTERACTION. THE DARK BLUE COLORED CLEANROOM SMOCK WORN BY ASSOCIATES WAS SENT ALSO SENT FOR FTIR TESTING TO DETERMINE THE MATERIAL TYPE, THE RESULTS INDICATE THAT THE SPECTRUM MATCHES REASONABLY WELL WITH PET. HOWEVER, WHEN EXAMINED UNDER 10X MAGNIFICATION UNDER WHITE LIGHT, THE SMOCK FIBERS WERE CLEARLY BLUE IN COLOR WHEN COMPARED TO THE BLACK FOREIGN MATTER. THEREFORE, THE SMOCK IS UNLIKELY THE SOURCE OF THE FOREIGN MATTER. WHILE PET IS A COMMON THERMOPLASTIC POLYMER MATERIAL THAT IS USED IN SYNTHETIC FIBERS, CONTAINERS, AND PACKAGING MATERIALS, HOWEVER, IT IS NOT USED IN THE MANUFACTURING FACILITY. THERE IS A POSSIBILITY THAT THE FOREIGN MATTER WAS INTRODUCED DURING PRODUCT APPLICATION OR HANDLING. WHILE THE SOURCE OF THE FOREIGN MATTER COULD NOT BE IDENTIFIED, THERE IS A PROJECT IN PLACE WITH IMPLEMENTED ACTIONS WHICH ADDRESSES LOOSE FOREIGN MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ANGIOCATH PLUS¿ I.V. CATHETER 22GA X 1.00IN EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER SUCH AS THREAD WAS FOUND IN CANNULA OF ANGIOCATH+ 22G.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: TWO PHOTOS AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. NO FOREIGN MATTER COULD BE OBSERVED FROM THE RETURNED PHOTOS AS THEY WERE UNCLEAR. ONE SAMPLE WITHOUT PACKAGING WAS RECEIVED FOR INVESTIGATION. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION TO CHECK FOR FOREIGN MATTER. ONE LOOSE BLACK THREAD-LIKE FOREIGN MATTER WAS OBSERVED ON THE SURFACE OF THE CATHETER TUBING. THE LOOSE BLACK THREAD-LIKE FOREIGN MATTER WAS SENT FOR FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING TO DETERMINE THE FOREIGN MATTER TYPE. THE RESULTS INDICATE THAT THE SPECTRUM REASONABLY MATCHES WITH THAT OF POLY(ETHYLENE TEREPHALATE). POLY(ETHYLENE TEREPHALATE) (PET) IS A THERMOPLASTIC POLYMER RESIN OF THE POLYESTER FAMILY AND IS USED IN SYNTHETIC FIBERS, CONTAINERS, THERMOFORMING IN MANUFACTURING, ENGINEERING RESINS, AND PACKAGING MATERIALS. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE MANUFACTURING PROCESS WAS REVIEWED AND THERE IS NO BLACK PET-BASED MATERIAL USED IN THE MANUFACTURING PROCESS. ALSO, THE MANUFACTURING PROCESS IS AUTOMATED, WITH MINIMAL HUMAN INTERACTION. THE DARK BLUE COLORED CLEANROOM SMOCK WORN BY ASSOCIATES WAS SENT ALSO SENT FOR FTIR TESTING TO DETERMINE THE MATERIAL TYPE, THE RESULTS INDICATE THAT THE SPECTRUM MATCHES REASONABLY WELL WITH PET. HOWEVER, WHEN EXAMINED UNDER 10X MAGNIFICATION UNDER WHITE LIGHT, THE SMOCK FIBERS WERE CLEARLY BLUE IN COLOR WHEN COMPARED TO THE BLACK FOREIGN MATTER. THEREFORE, THE SMOCK IS UNLIKELY THE SOURCE OF THE FOREIGN MATTER. WHILE PET IS A COMMON THERMOPLASTIC POLYMER MATERIAL THAT IS USED IN SYNTHETIC FIBERS, CONTAINERS, AND PACKAGING MATERIALS, HOWEVER, IT IS NOT USED IN THE MANUFACTURING FACILITY. THERE IS A POSSIBILITY THAT THE FOREIGN MATTER WAS INTRODUCED DURING PRODUCT APPLICATION OR HANDLING. WHILE THE SOURCE OF THE FOREIGN MATTER COULD NOT BE IDENTIFIED, THERE IS A PROJECT IN PLACE WITH IMPLEMENTED ACTIONS WHICH ADDRESSES LOOSE FOREIGN MATTER. THE ACTIONS IMPLEMENTED INCLUDE REVISING THE INSYTE CATHETER ASSEMBLY PROCEDURE TO INCLUDE REQUIRING THE CUT TUBING THERMOFORMING TRAYS BE CLEANED BEFORE STORAGE IN THEIR DESIGNATED CABINET TO ENSURE ALL THE TRAYS ARE CLEAN BEFORE USE, FABRICATING A CABINET TO KEEP THE CUT TUBING THERMOFORMING TRAYS AND STORE THEM IN A DESIGNATED AREA, FABRICATING COVERS TO ENSURE ALL GAPS/SMALL OPENINGS IDENTIFIED AT THE MACHINE ARE ENCLOSED, FABRICATING COVERS TO ENSURE THE MATERIAL LOADING STATION/GAP BETWEEN THE GUARD DOOR NEAR THE CATHETER ASSEMBLY STATION IS ENCLOSED, ADDING A VACUUM SUCTION TO REMOVE LOOSE FOREIGN MATTER THAT ADHERES ON THE CATHETER TIP AND CONTAINED IN THE COVER, UPDATING THE WEEKLY PREVENTATIVE MAINTENANCE TASK LIST TO INCLUDE CATHETER AND CANNULA LUBE CHAMBER CLEANING, AND FABRICATING A CABINET TO ENSURE ALL THE RAW MATERIAL IS PROPERLY STORED IN A DESIGNATED AREA. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ANGIOCATH PLUS¿ I.V. CATHETER 22GA X 1.00IN EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER SUCH AS THREAD WAS FOUND IN CANNULA OF ANGIOCATH+ 22G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616518 BD ANGIOCATH PLUS I.V. CATHETER 22GA X 1.00IN INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0325655

    Patients

    Seq Age Sex Outcome Treatment
    1