MAUDE Adverse Event Report: ANGIODYNAMICS, INC. BIOFLO DURAMAX; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 02-804

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2021

Event Type  malfunction  

Event Description

Patient had a perm cath inserted on (b)(6) 2021.It was identified on x-ray that there was a kink in the catheter near the apex in the neck.The patient was taken back to the operating room to have another perm cath inserted on (b)(6) 2021.Fda safety report id# (b)(4).

• Brand Name: BIOFLO DURAMAX
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 13207104
• MDR Text Key: 283617572
• Report Number: MW5106545
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02-804
• Device Lot Number: 5702806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White