MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LFS PPS PPY PENOLITEDSTMICRSL104IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142560488
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
Event occurred regarding a primary plum set, 0.2 micron filter, prepierced y-site, polyethylene lined light resistant tubing, distal microbore tubing, secure lock, 104 inch where they reported leakage at the filter during patient infusion.There was patient involvement but no patient harm as a result of this event.There is one quantity affected.Unknown drug was used and no unprotected drug exposure.
Additional Manufacturer Narrative
D9 - date returned to mfg is 9/16/2025.Received one (1) used list# 142560488, primary plum set for inspection.As received the inline filter appeared to be wetted out.No additional damage or anomalies were observed.Received one (1) phot of set in a bag.The set was leak tested per specifications.A leak was observed from the outlet and inlet of the inline filter.The complaint of leakage at filter can be confirmed.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter material due to an infusate interaction during use.

• Brand Name: LFS PPS PPY PENOLITEDSTMICRSL104IN
• 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: 22923633
• Report Number: 9615050-2025-00413
• Device Sequence Number: 13038351
• Product Code: FPA
• UDI-Device Identifier: 10887787005230
• UDI-Public: (01)10887787005230(17)280101(10)14222022
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: 142560488
• Device Lot Number: 14222022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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