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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO MIDLINE MIDLINE CATHETER

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ANGIODYNAMICS BIOFLO MIDLINE MIDLINE CATHETER Back to Search Results
Catalog Number 46490
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/13/2021
Event Type  malfunction  
Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress. The results of the investigation will be sent via a follow up medwatch. Reference (b)(4).
 
Event Description
A nurse reported an issue with a bioflo midline 5f dl-20cm max sterile barrier drape kit w/ two nitinol guidewires. During a procedure, there were issues with the guidewire and part of the wire was discovered to be left in the patient. This occurred when the doctor exchanged a picc with the midline catheter. The guidewire frayed/unraveled/stretched and part of it broke off. This was noticed when the doctor regained access at another site and it showed up on the x-ray. It was reported there was no resistance while trying to remove it. A new guidewire was used to complete the procedure. It was reported that the physician opted to leave the fragments in the patient as it was believed the patient would expel the fragment; however, the patient will be observed and has not experienced any adverse effects or harm as a result of this incident. The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
 
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Brand NameBIOFLO MIDLINE
Type of DeviceMIDLINE CATHETER
Manufacturer (Section D)
ANGIODYNAMICS
10 glens falls technical park
glens falls, ny 12801 NY 12801
MDR Report Key11900215
MDR Text Key253169746
Report Number1317056-2021-00104
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K161866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Catalogue Number46490
Device Lot Number5667007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/28/2021 Patient Sequence Number: 1
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