BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 22859975 · Received August 21, 2025

    Report

    Report Number
    22859975
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    August 9, 2025
    Report Date
    August 15, 2025
    Manufacturer
    FOOTPRINT MEDICAL, INC.
    Product Code
    LJS
    UDI-DI
    00858778006072
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    SINCE [DATE REDACTED] - LESS THAN ONE MONTH, HAVE BEEN 3 INDWELLING PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] REQUIRING REMOVAL DUE TO OCCLUSION. THEY HAVE ALL BEEN THE SAME BRAND AND LOT#, 1.4FR PICC(S) FROM THE FOOTPRINT BRAND, LOT# 250098. PATIENT 1: PICC PLACED [DATE REDACTED]. REMOVED: THREE DAYS LATER [DATE REDACTED] - UNABLE TO FLUSH/OCCLUDED PATIENT WAS RECEIVING BOTH TPN AND AMPICILLIN. TPN PAUSED AND LINE CLAMPED WHILE AMPICILLIN WAS GIVEN. PATIENT 2: PICC PLACED [DATE REDACTED]. REMOVED THE FOLLOWING DAY [DATE REDACTED] - UNABLE TO FLUSH/OCCLUDED PATIENT WAS RECEIVING BOTH TPN AND AMPICILLIN. TPN PAUSED AND LINE CLAMPED WHILE AMPICILLIN WAS GIVEN. ADDITIONAL PICC PLACED [DATE REDACTED], REMOVED (PULLED OUT) ON [DATE REDACTED] - APPROXIMATELY 30 DAYS LATER. AT THIS TIME THE CLOT WAS NOTED. PATIENT WAS TREATED FOR LEFT CEPHALIC SUPERFICIAL VENOUS THROMBUS. ADDITIONAL PICC PLACED [DATE REDACTED], LOVENOX (ENOXAPARIN) GIVEN TO TREAT THROMBOSIS. PICC WAS REMOVED ON [DATE REDACTED] - 10 DAYS LATER, WITH NO ISSUES WITH THE LINE. PATIENT 3: PICC PLACED [DATE REDACTED]. REMOVED [DATE REDACTED] - APPROXIMATELY 7 DAYS LATER - UNABLE TO FLUSH/OCCLUDED PATIENT WAS RECEIVING BOTH TPN AND AMPICILLIN. TPN PAUSED AND LINE CLAMPED WHILE AMPICILLIN WAS GIVEN. OCCLUSION OF PICC LINE WAS NOT IMMEDIATELY FOLLOWING AMPICILLIN INFUSION, BUT OCCURRED WITHIN 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2204549 NA CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS FOOTPRINT MEDICAL, INC. P1PIC1.4-S 250098 00858778006072

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA Male Required Intervention