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

MAUDE Adverse Event Report: MEDTRONIC MINIMED SILHOUETTE SET SET, ADMINISTRATION, INTRAVASCULAR

  • 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
 

MEDTRONIC MINIMED SILHOUETTE SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Difficult to Remove (1528)
Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330)
Event Date 02/08/2020
Event Type  malfunction  
Event Description
I prepared to change my infusion set site for my minimed 670g pump. I used the silhouette infusion sets and the "sil-serter" - the inserter that accompanies those sets. After i loaded a new set into the inserter and went to remove the needle from the new cannula, i could not dislodge the needle from the cannula at the new site. The needle, from i understand, is used to insert the cannula under the skin and once removed allows for the insulin reservoir to be attached or removed based upon activity or preference etc. Because i was unable to remove the needle from the new site and cannula, i had to completely remove the new infusion set and discard it. This led to extreme discomfort and bleeding. I also am not sure why the needle would not dislodge from the new set / cannula area after insertion. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSILHOUETTE SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key9720592
MDR Text Key180043832
Report NumberMW5093017
Device Sequence Number3
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/12/2020
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received02/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/14/2020 Patient Sequence Number: 1
-
-