MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EXT SET, SMALLBORE WITH CLAVE¿; STOPCOCK, I.V. SET

Catalog Number	011-C3302
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint involved a ext set, smallbore with clave¿.It was reported that there was black contamination found on the front part of the product tubing.There was no patient involvement, no patient harm and no delay in critical therapy.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
Received one (1) used list #011-c3302, ext set, smallbore with clave.The presence of a black particle inside the luer was confirmed.The black particle was compared to the tappi size estimation chart, these particles are acceptable per the criteria.These are a cosmetic error but do not affect function and are not loose in the fluid path.The particles are embedded in the plastic and not loose in the fluid path.Customer complaint of a black contamination is confirmed, probable cause is a molding error in manufacturing.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: EXT SET, SMALLBORE WITH CLAVE¿
• 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: 22282707
• Report Number: 9617594-2025-01273
• Device Sequence Number: 12966650
• Product Code: FMG
• UDI-Device Identifier: 00840619001537
• UDI-Public: (01)00840619001537
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 011-C3302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/01/2025
• 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
• Patient Sex: Unknown