• 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 VASACULAR UNKNOWN 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 VASACULAR UNKNOWN CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 09/10/2019
Event Type  Death  
Manufacturer Narrative

Qn# (b)(4). Additional information requested of the user facility by teleflex regarding this event. The customer responds and indicates that they are unable to answer our questions regarding this event. The customer reports that the device is available for onsite inspection. Note: the medwatch from the user facility did not have a uf/importer report#.

 
Event Description

According to the medwatch from the user facility "the pa catheter was discontinued from the two-lumen central venous access catheter. Two hours later, the patient coded, and bleeding was noted exiting the introducer".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW VASACULAR UNKNOWN
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
prazska 209
colonia panamericana, chihuahua
hradec kralove 04 500 0 4
EZ 500 04
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key9266346
MDR Text Key164620158
Report Number9680794-2019-00402
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER,USE
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 10/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberVASCULAR UNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2019
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: 11/01/2019 Patient Sequence Number: 1
-
-