MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142540489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.E1 initial reporter (full) phone number: (b)(6).
Event or Problem Description
The complaint/event involved an unspecified tubing set.The tubing was reportedly leaking at the in-line filter during a patient's infusion.There was no patient harm associated with the complaint/event.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint of 'the tubing leaking at in line filter' could not be confirmed by investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.A lot history review could not be conducted because no lot number was specified.
Event or Problem Description
Additional information was provided by the customer on 26apr2024.Three filter leaks were reported with primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch with the same lot number.The leaks were described as more of a condensation around the filter with a few drops surrounding the filter.There was no additional information provided.This emdr reflects 3 similar occurrences of the same failure mode and same product and lot number.
Additional Manufacturer Narrative
H.6 added imdrf b code - b14.As mentioned in previous supplemental report, the lot number was updated.The investigation was just updated to include device history: investigation summary: no product samples, pictures, or videos were received for investigation.The complaint of ' the tubing leaking at in line filter' could not be confirmed by investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed, no relevant nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU
• 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: 19377111
• Report Number: 9615050-2024-00408
• Device Sequence Number: 7549260
• Product Code: FPA
• UDI-Device Identifier: 10887787006039
• UDI-Public: (01)10887787006039(17)261001(10)13793809
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/25/2025

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 Expiration Date: 10/01/2026
• Device Catalogue Number: 142540489
• Device Lot Number: 13793809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/26/2024; 06/26/2024; 11/24/2025
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/28/2024; 08/22/2024; 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2023
• 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