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 it was stated that the facility has experienced a total of 3 filter leaks for both inpatient units and chemo suites.The leaks were described as more of a condensation around the filter with a few drops surrounding the filter.There was patient involvement and no human harm.There were a total of three occurrences.
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
Two pictures were returned.One showed the inline filter and the other showed a biohazard bag with a white note on it.Received four (4) new list #142540489 primary plum sets.As received no damage or anomalies were noted.Each set 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 tot he 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: 19390947
• Report Number: 9615050-2024-00414
• Device Sequence Number: 7761980
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2024

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?: 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: 06/14/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: UNSPECIFIED CHEMOTHERAPY DRUG, MFR UNK.
• Patient Sex: Unknown