Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 ARTERIAL CATH. SET: 24 GA X 5CM; 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 ARTERIAL CATH. SET: 24 GA X 5CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number SAC-00524-PBX
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/07/2020
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It is reported that the device was placed in or and then when babies were transferred to icu the "catheters stopped working after a few hours".Per physician the insertion procedure was completed with ultrasound and without complications, and catheters functioned in or well.
 
Event Description
It is reported that the device was placed in or and then when babies were transferred to icu the "catheters stopped working after a few hours".Per physician the insertion procedure was completed with ultrasound and without complications, and catheters functioned in or well.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW ARTERIAL CATH. SET: 24 GA X 5CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10082343
MDR Text Key192023738
Report Number3006425876-2020-00452
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K171146
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSAC-00524-PBX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-