MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC SURE T INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT 874

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/16/2018

Event Type  malfunction  

Event Description

Hold mc 05/03/2018 changed infusion site and noticed needle from his sure t infusion set remained in his leg.

• Brand Name: MEDTRONIC SURE T INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; northridge CA 91325
• MDR Report Key: 7478891
• MDR Text Key: 107240442
• Report Number: MW5076948
• Device Sequence Number: 0
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2018
• Device Model Number: MMT 874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 89