• 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: 3-LUMEN 7 FR X 16 CM CATHETER INTRAVASCULAR THERAPE

  • 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: 3-LUMEN 7 FR X 16 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CV-42703
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anaphylactic Shock (1703); Cardiac Arrest (1762); Reaction (2414)
Event Date 07/17/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information received: the resuscitation was successful following the cardiac arrest. The patient did not have a history of an allergy to chlorhexidine. The patient recovered well and surgical procedure was performed at a later date.
 
Event Description
It was reported that "anaphylactic shock to chlorhexidine impregnation on the line. Severe anaphylaxis, cardiac arrest required resuscitation, itu admission. Confirmed anaphylaxis to chlorhexidine with allergy testing".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW CVC SET: 3-LUMEN 7 FR X 16 CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
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 Key9172684
MDR Text Key161721484
Report Number3006425876-2019-00755
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K993691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCV-42703
Device Lot NumberUNKNOWN
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 Received11/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/09/2019 Patient Sequence Number: 1
-
-