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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 46027
Device Problem Fracture (1260)
Patient Problems Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)
Event Date 08/18/2021
Event Type  Injury  
Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation. The results of the investigation will be sent via a follow up medwatch. Reference (b)(4).
 
Event Description
A director of quality/ risk management reported an issue with a bioflo midline 4f sl-20cm max sterile barrier nursing kit w df drape and two nit pg. During an insertion procedure, the patient's vein was accessed using the needle and the physician attempted to advance the guidewire but the patient moved and access was lost. The physician was unable to remove the guidewire; therefore, an interventional radiologist (ir) went to the patient's bedside to evaluate. The ir was able to remove the guidewire; however, the tip of the wire was not intact and an x-ray revealed that a piece was remaining in that patient's arm. The ir removed the wire and serial xrays of arm and chest were performed, as well as an ultrasound of the arm which revealed a thrombus. The patient was sent to (b)(6) medical center for further evaluation on (b)(6) 2021 with no further information at this time. The reported device is not available to be returned to the manufacturer for evaluation.
 
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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
Manufacturer (Section G)
ANGIODYNAMICS
10 glens falls technical park
glens falls, ny 12801 NY 12801
Manufacturer Contact
alexandra invencio
26 forest street
marlborough, MA 01752
5086587805
MDR Report Key12407897
MDR Text Key269349275
Report Number1317056-2021-00163
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 User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number46027
Device Lot Number5682709
Was Device Available for Evaluation? No
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2021
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: 09/01/2021 Patient Sequence Number: 1
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