MAUDE Adverse Event Report: MEDTRONIC MINIMED QUICK SET INFUSION SET 23 INCH TUBING 9MM CANNULA; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Date 05/03/2018

Event Type  Injury  

Event Description

Pt was in dka d/t a kinked infusion set cannula.She uses quick set by medtronic and this is the 3rd admission for the same problem."event abated after use stopped or dose reduced: yes." route: subcutaneous.Therapy start date: (b)(6) 2018; therapy end date: (b)(6) 2018.

• Brand Name: QUICK SET INFUSION SET 23 INCH TUBING 9MM CANNULA
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 7493896
• MDR Text Key: 107767666
• Report Number: MW5077031
• Device Sequence Number: 1
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 30 YR
• Patient Weight: 88