MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 2 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER; SET, ADMINISTATION, INTRAVASCULAR

Catalog Number	121939290
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending completion.
Event or Problem Description
The event involved a primary plum set, 2 clave multiport connector, ball check valve in sight chamber, 15 micron filter, clave secondary port, clave y-site, polyethylene lined light resistant tubing, secure lock, 213 cm where it was reported that it began to leak with the administration of the premedication.Although the event occurred during infusion, there was no patient harm.
Additional Manufacturer Narrative
Investigation summary received one (1) used list# 121939290, primary plum set connect to one (1) used list# unknown, needle for inspection.There was a tear on the tube below the bag spike.The tear through the tube was a straight and clean cut.No other damage and anomalies were noted.The packaging was returned and no damage or anomalies were observed.Received three (3) photos, one (1) photo of the torn tubing, one (1) photo of the set, and one (1) photo of the packaging.The sample leaked.The reported complaint of leak can be confirmed.The probable cause is due to interactions with a sharp object.The manufacturing process was reviewed and there are no sharp objects or instruments on the manufacturing floor capable of the observed damage as a preventative measure.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, 2 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER
• Common Device Name: SET, ADMINISTATION, 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: 23303440
• Report Number: 9615050-2025-00478
• Device Sequence Number: 18690418
• Product Code: FPA
• UDI-Device Identifier: 00887709100121
• UDI-Public: (01)00887709100121(17)271201(10)14217631
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 121939290
• Device Lot Number: 14217631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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