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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP
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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CV-25703
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "at the time of passing the guide for catheter placement, the guide with small rupture is evident.It was decided to use another catheter without problems." no patient injury or complication reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The complaint is reported as: "at the time of passing the guide for catheter placement, the guide with small rupture is evident.It was decided to use another catheter without problems." no patient injury or complication reported.The patient's condition is reported as fine.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 7FR X 20CM
Type of Device
CATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11347562
MDR Text Key232514562
Report Number3006425876-2021-00158
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,foreig
Type of Report Initial,Followup
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCV-25703
Device Lot Number14F20J0077
Was Device Available for Evaluation? No
Date Manufacturer Received03/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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