MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142300490
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation, however, it has not yet been received.
Event or Problem Description
An event involving a secondary set, secure lock, with iv set hanger, 34 inch report stated that the secondary line was leaking from the vent.The patient was on immunotherapy with zolbetuximab.Nurse noticed the wet on her hand.It was few drops.Nurse washed her hand with soap and water.The tubing was then changed by pharmacy under the hood.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Received one used list #142300490, secondary set, secure lock, with iv set hanger.As received, no damage or anomalies noted.Received two photos, one of the set and one of the packaging.The set was leak tested per specifications and no leakage was observed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.The complaint of a leakage cannot be replicated or confirmed.D9 - date returned to mfr: 10feb2026.Corrected information can be found in e4 - initial report sent to fda, h6 health effect - clinical code and h6 component code.

• Brand Name: SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH
• 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: 24265151
• Report Number: 9615050-2026-00057
• Device Sequence Number: 10031169
• Product Code: FPA
• UDI-Device Identifier: 10887787006268
• UDI-Public: (01)10887787006268(17)280801(10)14449283
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142367
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 142300490
• Device Lot Number: 14449283
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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: ZOLBETUXIMAB, UNK MFR.
• Patient Sex: Unknown