MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 80/9 HCAP 3-PK INT

Lot Number 6004067

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 (b)(6) 2024, it was reported that patient's infusion set's cord (tubing) got stuck on the knob while standing.The site location was right side of patient's abdomen, with the pump on the right side.Moreover, the infusion had been used for one day.Reportedly, 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 available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 80/9 HCAP 3-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19010077
• MDR Text Key: 339009528
• Report Number: 8021545-2024-00135
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244023314
• UDI-Public: 05705244023314
• 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: 04/01/2024

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: 6004067
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/01/2024
• Patient Sequence Number: 1