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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIODYNAMICS, INC. BIOFLO MIDLINE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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ANGIODYNAMICS, INC. BIOFLO MIDLINE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 5 F
Device Problems Difficult to Remove (1528); Unraveled Material (1664)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/22/2020
Event Type  malfunction  
Event Description
Midline being inserted. Guidewire would not easily come out of needle. Nurse began to remove needle with guidewire and wire began to unravel. Physician called and he removed. X-ray done. Piece of guidewire in tissue of patient's arm. Fda safety report id# (b)(4).
 
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Brand NameBIOFLO MIDLINE
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ANGIODYNAMICS, INC.
MDR Report Key10384390
MDR Text Key202366645
Report NumberMW5095958
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5 F
Device Lot Number5589127D
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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