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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE

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ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-27702-E
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the connection of the ars syringe and needle was not secure during patient puncture. No patient harm reported. The patient's condition is reported as fine.
 
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Brand NameARROW CVC SET: 2-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
MDR Report Key12348611
MDR Text Key267485616
Report Number3006425876-2021-00780
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCS-27702-E
Device Lot Number71F20J2258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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