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

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).

• Brand Name: SILHOUETTE SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 9720592
• MDR Text Key: 180043832
• Report Number: MW5093017
• Device Sequence Number: 3
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR