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	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporter (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 that there was leakage noted at the prepierced y-site during infusion.There was one quantity affected.There was unknown drug used and no unprotected chemo exposure.There was patient involvement, but no patient harm.
Additional Manufacturer Narrative
Received one used list #142560488, primary plum set for evaluation.The set was examined under uv light and the tube was not bonded concentrically with the inlet on the y-site.No damage or other anomalies were observed.Received three photos of the set.One photo showed the set in a bag and two photos showed the y-site.Leakage was observed around the inlet on the y-site.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.The complaint of leakage can be confirmed.The probable cause is due to a manual bonding error during manufacturing.D9 date returned to mfg: 9/3/2025.

• 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: 22841680
• Report Number: 9615050-2025-00394
• Device Sequence Number: 9463661
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: 07/23/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DRUG, UNKOWN MFR.
• Patient Sex: Unknown