BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 14477134 · Received May 23, 2022

    Report

    Report Number
    8041187-2022-00262
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    February 23, 2022
    Report Date
    June 28, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 14-JUN-2022. H6: INVESTIGATION SUMMARY FOUR PHOTOS AND FOUR ACTUAL SAMPLES WITH OPEN PACKAGING WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTOS, THE NEEDLE CATHETER TIP WAS OBSERVED TO BE DAMAGED. TWO PIECES WERE RECEIVED FROM BATCH 1140032, ONE PIECE WAS RECEIVED FROM BATCH 1173616, AND ONE PIECE WAS RECEIVED FROM BATCH 1203493. THE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION TO CHECK FOR CATHETER DAMAGE. FROM THE RETURNED SAMPLES, THE TEAM OBSERVED THE NEEDLE PIERCED THROUGH THE CATHETER NEAR THE TIP AREA. 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 ASSEMBLY PROCESS WAS REVIEWED. IF THE NEEDLE PIERCED THROUGH CATHETER OCCURRED IN THE MANUFACTURING PROCESS, THE DEFECT WOULD BE DETECTED AND AUTO REJECTED BY THE INLINE TIP SPEAR VISION INSPECTION SYSTEM. NEEDLE PIERCED THROUGH CATHETER COULD ALSO HAPPEN DURING PRODUCT APPLICATION WHEN THE PRODUCT WAS MANIPULATED OR DURING THE NEEDLE COVER REMOVAL IF NOT DONE CAREFULLY. THE FOLLOWING CONTROLS HAVE BEEN PUT IN PLACE TO PREVENT AND DETECT THE NEEDLE BEING PIERCED THROUGH CATHETER FROM OCCURRING: THE VISION SYSTEM CAMERA IS NOT OUT OF FOCUS WHEN CAPTURING THE DEFECT BY USING VARIOUS METAL BLOCKS FOR DIFFERENT GAUGES TO PREVENT THE VISION ASSEMBLY FROM DROPPING UNDER ITS WEIGHT AND THE CATHETER IS ALIGNED TO ONE SIDE USING VACUUM TO AID THE INSERTION OF THE CANNULA THUS REDUCING THE LIKELIHOOD OF THIS NONCONFORMANCE FROM OCCURRING. A DAILY CHALLENGE OF THE VISION SYSTEM IS PERFORMED, AND VISUAL INSPECTION IS PERFORMED DURING OUTGOING INSPECTION. 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 H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD ANGIOCATH¿ IV CATHETER, THE CATHETER WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANGIO CATHETER TUBE IS TORN AND DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD ANGIOCATH¿ IV CATHETER, THE CATHETER WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANGIO CATHETER TUBE IS TORN AND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354080 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1173616

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown