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	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that, on an unknown date, a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch are generating leaking in high frequency in the chemo suites.During patient use.The medication involved was mannitol.There were no holes, cuts, tears or any defects noted.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
The complaint of leakage was confirmed on the returned new 142540489 primary plum set.The set was attached to an icu medical-provided intravenous (iv) bag, primed per packaging directions, and a test infusion of 10 ml at 400 ml/hr as infused per 90.P-1137 was performed.No errors or alarms were generated, and no restrictions were noted.The returned sample was leak-tested per product specification.There was a leak observed from the inline filter.A green dye test was performed where the leak was observed to be coming from a small, centralized location on the inlet filter.The probable cause of the observed leak was due to a pinhole in the filter vent material.The damage is typical of an electrostatic discharge to the filter vent that occurred during manufacturing in costa rica.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.D9: date returned to mfg: 1/18/2024.

• 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: 18460894
• Report Number: 9615050-2024-00021
• Device Sequence Number: 19608195
• 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): 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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: MANNITOL, UKN MFR.
• Patient Sex: Unknown