MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 84" (213 CM) APPX 10.5 ML, 15 DROP PRIMARY SET W/4-WAY STOPCOCK, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B30178
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint involved an 84" (213 cm) appx 10.6 ml, 15 drop primary set w/4-way stopcock, spin luer.The reporter stated that a particular set of iv tubing had some sort of dirt on the inside of the tubing.It was used on a patient and seen when they went to clamp the tubing after placing the iv.There was patient involvement, no injury and no death.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
Investigation summary: one (1) photo was provided by the customer that confirms the complaint of some sort of contamination in the drip chamber.Received one (1) used.List #b30178, 84" (213 cm) appx 10.6 ml, 15 drop primary set returned for evaluation.As received a contamination was observed inside the drip chamber.Burnt embedded material was observed on the drip chamber of the set.The drip chamber was cut open and the material was confirmed to be embedded in the wall and not loose in the fluid path.The reported complaint of the iv tubing had some sort of dirt on the inside can be confirmed.The probable cause is due to an error during molding in costa rica.A device history record lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 84" (213 CM) APPX 10.5 ML, 15 DROP PRIMARY SET W/4-WAY STOPCOCK, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22162876
• Report Number: 9617594-2025-01167
• Device Sequence Number: 21184330
• Product Code: FMG
• UDI-Device Identifier: 00887709004917
• UDI-Public: 00887709004917
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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 Catalogue Number: B30178
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: IV TUBING, MFR UNK
• Patient Sex: Unknown