• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Reaction (2414)
Event Date 07/16/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer reports that the catheter was inserted, on (b)(6) 2019, before an operation and was used for transfusion after the operation. On (b)(6) 2019, the patient had a sudden high fever and shivers. Lysine and aspirin were used for recovering the temperature and the transfusion was stopped. The temperature didn't rise, and the catheter was removed. Bacterial culture of the catheter tip indicated no bacteria.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8883071
MDR Text Key153975809
Report Number3006425876-2019-00589
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,Followup
Report Date 07/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device EXPIRATION Date08/22/2020
Device Catalogue NumberCS-27702-E
Device LOT Number71F18H1400
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2019
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

Patient TREATMENT DATA
Date Received: 08/12/2019 Patient Sequence Number: 1
-
-