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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 Problems Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/22/2020
Event Type  malfunction  
Manufacturer Narrative
It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation. To date the device has yet to be returned. An investigation into the root cause for incident is currently in progress. The results of the investigation will be sent via a follow up medwatch. Complaint reference (b)(4).
 
Event Description
An angiodynamics clinical specialist reported an issue during a midline insertion procedure. During the procedure, the access wire was stuck in the patient's arm. The inserter opted to have a doctor remove the wire; it was indicated the wire was pulled back through the access needle, however, when this was performed, a small piece of the wire was retained in the patient's arm. The fragment was not removed as it was embedded in the patient's soft tissue. Surgery had been consulted and the surgeon determined removal was not needed. It was indicated the reported device is available for return to the manufacturer for a device evaluation.
 
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Brand NameBIOFLO MIDLINE
Type of DeviceMIDLINE CATHETER,,
Manufacturer (Section D)
ANGIODYNAMICS
603 queensbury avenue
queensbury NY 12804
Manufacturer (Section G)
ANGIODYNAMICS
603 queensbury avenue
queensbury NY 12804
Manufacturer Contact
alexandra invencio
26 forest street
marlborough, MA 01752
5086587805
MDR Report Key10424610
MDR Text Key203456977
Report Number1317056-2020-00140
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number46490
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
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: 08/19/2020 Patient Sequence Number: 1
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