• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; 1LYRTR 14FR10ML100%SILTMP SNAP

  • 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
 

MEDLINE INDUSTRIES, LP Medline Industries, Inc.; 1LYRTR 14FR10ML100%SILTMP SNAP Back to Search Results
Model Number URO175814T
Device Problem Material Integrity Problem (2978)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/30/2023
Event Type  Injury  
Event Description
According to the facility the sample port detached requiring the catheter to be replaced.
 
Manufacturer Narrative
According to the facility the sample port detached requiring the catheter to be replaced.No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
Medline Industries, Inc.
Type of Device
1LYRTR 14FR10ML100%SILTMP SNAP
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093
Manufacturer Contact
justin herrmann
three lakes drive
northfield, IL 60093
MDR Report Key16961433
MDR Text Key315552627
Report Number1417592-2023-00223
Device Sequence Number1
Product Code OHR
UDI-Device Identifier10193489987522
UDI-Public10193489987522
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberURO175814T
Device Catalogue NumberURO175814T
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/03/2023
Initial Date FDA Received05/19/2023
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
-
-