MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, S; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	15247-28
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.The device has been requested for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
A complaint was received regarding a primary plum set, clave secondary port, clave y-site, distal microbore tubing, secure lock, 104 inch that experienced leakage during use.It was stated in the report that the product has leaking from the vent port near the spike while patient receiving tpn.There was patient involvement.There was no report of patient harm.
Additional Manufacturer Narrative
One used device was returned for evaluation.As received, no damage or anomalies were noted.The set was leak tested per specifications and no leakage was observed.The complaint of leak out of the vent cannot be replicated or confirmed.Lot history review could not be conducted because no lot number(s) was/were identified.Additional information d9 section.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, S
• 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: 22804838
• Report Number: 9617594-2025-01679
• Device Sequence Number: 7797862
• Product Code: FPA
• UDI-Device Identifier: 00887709102057
• UDI-Public: 00887709102057
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,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: 15247-28
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: TOTAL PARENTERAL NUTRITION (TPN), MFR UNK.
• Patient Sex: Unknown