MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 80/9 HCAP 1-PK INT

Lot Number 6002063

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states on 26-mar-2024, it was reported by patient's mother that her son's infusion set tubing came apart at the tubing connector when the patient collided with a fellow student.The site location was left side of patient's abdomen and the pump was clipped on the waist of his pants.The infusion had been used for five days.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information was available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 80/9 HCAP 1-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19017949
• MDR Text Key: 339093485
• Report Number: 8021545-2024-00136
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244023079
• UDI-Public: 05705244023079
• Combination Product (y/n): N
• PMA/PMN Number: K210544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 6002063
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/02/2024
• Patient Sequence Number: 1