• 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 STERILIZATION TUBING ROLL WRAP, STERILIZATION

  • 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 STERILIZATION TUBING ROLL WRAP, STERILIZATION Back to Search Results
Model Number MPP200420S
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2020
Event Type  malfunction  
Event Description
The tip of the catheter broke off.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTERILIZATION TUBING ROLL
Type of DeviceWRAP, STERILIZATION
Manufacturer (Section D)
MEDLINE INDUSTRIES
three lakes drive
northfield IL 60093
MDR Report Key10020252
MDR Text Key189741694
Report Number10020252
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/27/2020,03/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMPP200420S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2020
Event Location No Information
Date Report to Manufacturer05/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-