MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142550489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
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
The event involved a primary plumset, 0.2 micron filter, clave y-site, pe lined tubing, 104 inch and it was reported that the patient had an epoch (doxorubicin, etoposide or vepesid, vincristine sulphate) bag hung at 6:44pm using icu medical primary plum set tubing with a 0.2-micron filter.On the following day, around 6:30pm, when the registered nurse took the epoch bag down, the abdominal pad that had been wrapped around the filter by the rn who had hung the bag was examined, and it was noted to have 2 drops of chemotherapy on the pad.The entire setup was placed into a chemo bag and was returned to the pharmacy.There was patient involvement, and no reported patient harm.

• Brand Name: PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 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: 24922428
• Report Number: 9615050-2026-00241
• Device Sequence Number: 18430062
• Product Code: FPA
• UDI-Device Identifier: 10887787005971
• UDI-Public: (01)10887787005971(17)280701(10)14445268
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: 142550489
• Device Lot Number: 14445268
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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: ABDOMINAL PAD, UNK MFR; DOXORUBICIN ((B)(6)) 18 MG, PFIZER; EPOCH BAG, UNK MFR; ETOPOSIDE ((B)(6))92 MG, HIKMA PHARMACEUTICAL; PORT-A-CATH, UNK MFR; VINCRISTINE ((B)(6)) 0.7MG, HOSPIRA
• Patient Age: 74 YR
• Patient Sex: Male