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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRNIC MINIMED SIL-SERTER INTRODUCER, SYRINGE NEEDLE

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MEDTRNIC MINIMED SIL-SERTER INTRODUCER, SYRINGE NEEDLE 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).
 
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Brand NameSIL-SERTER
Type of DeviceINTRODUCER, SYRINGE NEEDLE
Manufacturer (Section D)
MEDTRNIC MINIMED
MDR Report Key9720592
MDR Text Key180043832
Report NumberMW5093017
Device Sequence Number2
Product Code KZH
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
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