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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CS-27702-E
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. 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. Corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without a sample. Teleflex will continue to monitor and trend for reports of this nature.

 
Event Description

The customer reports: the catheter was found blocked during usage of iv transfusion. A new device was used.

 
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Brand NameARROW CVC SET: 2-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
margie burton, rn
3015 carrington mill blvd
morrisville, NC 27560
9194334965
MDR Report Key8785358
MDR Text Key150851164
Report Number3006425876-2019-00477
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/12/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date08/23/2020
Device Catalogue NumberCS-27702-E
Device LOT Number71F18H1402
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/13/2018
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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