MAUDE Adverse Event Report: MEDTRONIC MINIMED INF SET, QUICK SET 23'' 6MM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2022

Event Type  malfunction  

Event Description

Spontaneous.Mother reports occlusion alarm on remunity remote.Author informed mother to inspect line for any kinks, mother found a "slit" in the tubing that looked like it could be causing the issue.Author informed mother that the infusion set would be replaced along with the cartridge.Mother requested call back in 30 minutes while she sets up the new cartridge to ensure everything is up and running.Author called mother back and everything was running fine.No further information, details or dates available.Sq remunity specialty pharmacy fill pt.Unknown serial number of pump.Unknown if available for return.Reported to (b)(6) by pt/caregiver.

• Brand Name: INF SET, QUICK SET 23'' 6MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 15987028
• MDR Text Key: 305527701
• Report Number: MW5113794
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 12/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: PUMP; REMUNITY
• Patient Age: 4 YR
• Patient Sex: Female