MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, CLAVE Y-SITE, 104 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1424228
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary plumset, clave y-site, 104 inch where it was reported that the customer found an iv primary tubing set that had dirt specks in the cassette.There were 2 pieces of dirt in the cassette.There was no report of patient involvement or patient harm.
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is not yet complete.
Additional Manufacturer Narrative
Received one opened/unused.List #142420489, primary plumset, clave y-site, 104 inch; lot #5617794.The complaint of foreign matter in the cassette of the 142730490 plum set can be confirmed.There was burnt material observed in the wall of the cassette.The cassette was cut open and the particle was confirmed to be embedded in the wall, not in the fluid path.The particles met the specification of allowable surface area of embedded or attached foreign material per product specifications.The probable cause of the embedded material is during molding in manufacturing.The embedded material is not in the fluid path and does not affect the functionality of the device.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUMSET, CLAVE Y-SITE, 104 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15013770
• Report Number: 9615050-2022-00145
• Device Sequence Number: 6819779
• Product Code: FPA
• UDI-Device Identifier: 10887787006237
• UDI-Public: (01)10887787006237(17)240901(10)5617794
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 09/01/2024
• Device Model Number: 1424228
• Device Catalogue Number: 142420489
• Device Lot Number: 5617794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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