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 Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch where it was reported there was leakage from intravenous tubing to the site of the droplet filter.The patient noted a cold and damp sensation on her arm and the nurse noted the presence of a drip from the filter used for this medication.The patient did come into contact with a small amount of chemo (a few drops).The healthcare provider was wearing their protective equipment (epi) and did not have direct contact with the leaking cytotoxic drug.The patient¿s skin was cleaned with water and soap.The patient had contact on their right forearm with a few drops.The healthcare provider has not been exposed to chemotherapy drugs in an unprotected manner.The procedure of spillage for such an incident has been followed, which included a contact of the chemotherapy agent with the patient¿s skin and the cleaning team subsequently handled the cleanup.A spill kit was used.There were no visible holes, cuts, or tears.However, a very slight leak occurred at the end of the infusion through the filter cassette, closest to the patient.The patient completed her treatment after the spill was contained and her skin was cleaned.There was a loss of 5 ml when the tubing was changed and a slight delay in therapy.There was patient involvement and unknown patient harm.
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation, however, sample photos were provided.Investigation is pending.Additional reporter: (b)(6).
Additional Manufacturer Narrative
Received a series of photos showing the packaging information and the 142540489 primary plum set.The outlet filter vent on the 0.2 micron filter was indicated as the area of leakage.There was no leakage observed.The reported complaint of leakage could not be confirmed from the photo provided.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history review (dhr) for lot 13684576 was reviewed and no nonconformities were found that would have led 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: 18579846
• Report Number: 9615050-2024-00071
• Device Sequence Number: 8491938
• Product Code: FPA
• UDI-Device Identifier: 10887787006039
• UDI-Public: (01)10887787006039(17)260701(10)13684576
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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: 07/01/2026
• Device Catalogue Number: 142540489
• Device Lot Number: 13684576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CISPLATIN, UNK MFR; MANNITOL, UNK MFR
• Patient Sex: Female