MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDHP 0.2 MICRN HP CL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	206680428
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a lfieshield¿ extension set - 17 inch 0.2 micron filter, clave¿ y-site, non-dehp that experienced leakage and air in line.It was reported that there was a leakage from the tubing specifically the tubing part of the filter was leaking tpn and air was getting in.Additionally, there are one or two pin holes in the actual tubing and leaking the fluid through the holes.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.D4 and h4 the lot#, expiration date, and manufacture date are unknown.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Additional Manufacturer Narrative
One used device was received for evaluation.As received, there was a small hole in the tubing.No other damages or anomalies noted.The set was leak tested per product specification.There was a leak from the hole observed.There were no other leaks or damages observed.The probable cause of the small hole observed in the tubing is unknown.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: NDHP 0.2 MICRN HP CL
• 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: 21938644
• Report Number: 9615050-2025-00199
• Device Sequence Number: 12060262
• Product Code: FPA
• UDI-Device Identifier: 10887787005919
• UDI-Public: 10887787005919
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 206680428
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/18/2025
• 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