MAUDE Adverse Event Report: OTHER ACCESSORIES; Set, administration, intravascular

Model Number	INFUSION DEVICES - UNKNOWN ICD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 8021545.Manufacturing site: 8021545.
Event or Problem Description
It was reported by the patient that the infusion set cannula was not coming apart resulting in pump functioning.The patient was having symptoms like shaking and flu.

• Brand Name: OTHER ACCESSORIES
• Common Device Name: Set, administration, intravascular
• Manufacturer Contact: pamela meadows ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; 3367062840
• MDR Report Key: 24739691
• Report Number: 8021545-2026-03052
• Device Sequence Number: 9790827
• Product Code: FPA
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: INFUSION DEVICES - UNKNOWN ICD
• Device Lot Number: 6013849
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 06/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown