MAUDE Adverse Event Report: INFUSION DEVICES - UNKOWN

Lot Number UNKNOWN

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 (b)(6).The patient reported that the infusion set broke completely.She stated that the tubing from the clip that goes into the cannula had separated completely from rest of the set.It happened where the tubing broke off and the second time the exact same thing happened.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: 9514515
• MDR Text Key: 183279632
• Report Number: 3003442380-2019-01989
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/24/2019
• Type of Device Usage: N
• Patient Sequence Number: 1