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

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).

• Brand Name: BIOFLO MIDLINE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 10384390
• MDR Text Key: 202366645
• Report Number: MW5095958
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5 F
• Device Lot Number: 5589127D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 119