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U.S. Department of Health and Human Services

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

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ANGIODYNAMICS, INC. BIOFLO DURAMAX; CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
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).
 
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Brand Name
BIOFLO DURAMAX
Type of Device
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
ANGIODYNAMICS, INC.
MDR Report Key13207104
MDR Text Key283617572
Report NumberMW5106545
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Number02-804
Device Lot Number5702806
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/07/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age51 YR
Patient SexFemale
Patient Weight66 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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