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: MERIT MEDICAL SYSTEMS, INC. IMPRESS NON-BRAIDED PERIPHERAL CATHETER
  • 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
 

MERIT MEDICAL SYSTEMS, INC. IMPRESS NON-BRAIDED PERIPHERAL CATHETER Back to Search Results
Model Number 00884450026571
Device Problems Fracture (1260); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2020
Event Type  malfunction  
Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that the black tip at the end of the catheter go detached and lodged inside another catheter.The account states that they were able to retrieve the tip.No patient injury.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, the root cause could not be determined; however, it is likely that significant force was applied to the device during use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IMPRESS NON-BRAIDED PERIPHERAL CATHETER
Type of Device
PERIPHERAL CATHETER
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
14646 kirby drive
houston, tx
MDR Report Key10317243
MDR Text Key200432569
Report Number3010665433-2020-00024
Device Sequence Number1
Product Code DQO
UDI-Device Identifier00884450026571
UDI-Public00884450026571
Combination Product (y/n)N
PMA/PMN Number
K053171
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/20/2023
Device Model Number00884450026571
Device Catalogue Number46538KA2
Device Lot NumberE1770469
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Date Manufacturer Received08/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-