MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP LS 5.25IN MICROB EXT SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126506628
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a ndehp ls 5.25in microb ext set.The customer reported that the intravenous (iv) was "non-infusing".There was no report of human harm associated with the reported issue.
Additional Manufacturer Narrative
Received a photo from the customer showing the packaging of the sample.No conclusions could be made from the photo.The reported complaint of "non-iv infusing" could not be confirmed from the photo received.Without the return of the sample, a comprehensive review cannot be performed and a probable cause cannot be determined.No lot provided for a device history record review.

• Brand Name: NDEHP LS 5.25IN MICROB EXT SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21599442
• Report Number: 9615050-2025-00119
• Device Sequence Number: 21064171
• Product Code: FPA
• UDI-Device Identifier: 10887787005490
• UDI-Public: 10887787005490
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 126506628
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown