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	11/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch generated a leak.The patient was placed on a normal saline (ns) flush post paclitaxel infusion when the registered nurse (rn) noted the filtered tubing leaking at the posterior side with 2 drops of clear fluid noted on the patient's sweater.The patient's sweater was removed and placed into a clear garbage bag, and washing instructions were given to the patient's daughter.No moisture was noted on the patient's shirt underneath or her skin.The patient¿s tubing was changed for carboplatin.There was no patient harm reported.
Additional Manufacturer Narrative
Received two (2) photos showing the packaging information.No damages or anomalies were noted.The complaint of leakage on the 142730490 could not be confirmed by the investigation.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: 18509329
• Report Number: 9615050-2024-00035
• Device Sequence Number: 7950587
• 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): 01/31/2024

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: 12/13/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 01/31/2024
• 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: NORMAL SALINE, UNK MFR.; PACLITAXEL, UNK, MFR.
• Patient Sex: Unknown