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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSUFLON CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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INSUFLON CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 98-000-2612
Device Problems Contamination (1120); Difficult to Insert (1316); Unintended Movement (3026); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/06/2021
Event Type  malfunction  
Event Description
2 products failed prior to using on patient. 1st insuflon opened bevel on needle unable to place bevel up and insert. Bevel turned to side when tan plastic portion that is to lay flat on skin was flat. Did not place 2nd insfulon opened dressing stuck to top of package and between package and top. Not able to use due to risk of contamination.
 
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Brand NameINSUFLON
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12352766
MDR Text Key267676439
Report Number12352766
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 08/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98-000-2612
Device Lot Number5321784
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/17/2021
Event Location Hospital
Date Report to Manufacturer08/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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