MAUDE Adverse Event Report: INFUSION DEVICES - UNKOWN

Lot Number 5299877

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that two nights ago, the patient's infusion set's tubing became detached from trident clip at site (tubing broke).There was no damage when the package was first opened.Reportedly, the infusion was replaced, and insulin was resumed successfully.No further information available.

• Brand Name: INFUSION DEVICES - UNKOWN
• Type of Device: INFUSION DEVICES - UNKOWN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 10447243
• MDR Text Key: 204227841
• Report Number: 3003442380-2020-00366
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/01/2023
• Device Lot Number: 5299877
• Date Manufacturer Received: 08/19/2020
• Type of Device Usage: N
• Patient Sequence Number: 1