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	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch and was received from a sr.Specialist, post market vigilance of cardinal health/distributor.The customer reported that the device leaked at the filter during chemotherapy (unspecified) infusion.The leak was described as condensation around the filter with a few drops surrounding the filter.There was patient involvement and no human harm reported.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation; however, it is has not yet been received.E1 - contact extension number contact fax number - (b)(6).Distributor contact information.Cardinal health canada (b)(4).
Additional Manufacturer Narrative
D9 - device returned for evaluation 5/24/24.A picture showing a biohazard bag was returned.Received one (1) new list #142540489 primary plum set.No damage or anomalies noted on the received set.The et was leak tested per specification.No leakage was observed.The complaint of filter leaks could not be replicated or confirmed.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 and no 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: 19397641
• Report Number: 9615050-2024-00423
• Device Sequence Number: 17881361
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: 10/01/2026
• Device Catalogue Number: 142540489
• Device Lot Number: 13793809
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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