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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4FR X 8CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4FR X 8CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-25402
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "the proximal lumen was blocked; they place the catheter with this condition and they made a knot in the proximal lumen. " no patient harm 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. A device history record review was performed and 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: "the proximal lumen was blocked; they place the catheter with this condition and they made a knot in the proximal lumen. " no patient harm reported. The patient's condition is reported as fine.
 
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Brand NameARROW CVC SET: 2-LUMEN 4FR X 8CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12328475
MDR Text Key266871736
Report Number3006425876-2021-00736
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 07/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/09/2022
Device Catalogue NumberCS-25402
Device Lot Number71F21A1372
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2021
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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