MAUDE Adverse Event Report: QUICK SET; UNO QUICK-SET 60/9 MGBW

Model Number MMT-392

Device Problem Appropriate Term/Code Not Available (3191)

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) 2023, the patient's mother reported that, a few days ago, there was a small crack and subsequent leakage in one of the needles of the infusion set.No further information available.

• Brand Name: QUICK SET
• Type of Device: UNO QUICK-SET 60/9 MGBW
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 17314584
• MDR Text Key: 319871404
• Report Number: 3003442380-2023-00301
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006294
• UDI-Public: 05705244006294
• Combination Product (y/n): Y
• PMA/PMN Number: K991759
• 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: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MMT-392
• Device Lot Number: 5404440
• Date Manufacturer Received: 07/05/2023
• Patient Sequence Number: 1