MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE®, LUER LO; STOPCOCK, I.V. SET

Catalog Number	B33895
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
It was reported that, on an unknown date, a 107" (272 cm) appx 8.7 ml, transfer set w/dual check valve, microclave®, luer lock was found to have a failing valve during patient use.The report stated that the item had a valve failing during medication administration.The sample was available for investigation.There was no patient harm reported.
Additional Manufacturer Narrative
No b33895 product samples, videos or photographs were returned for investigation.The device history report (dhr) was reviewed and there were no non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE®, LUER LO
• 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: 20183417
• Report Number: 9617594-2024-01277
• Device Sequence Number: 15629370
• Product Code: FMG
• UDI-Device Identifier: 00887709072640
• UDI-Public: (01)00887709072640(17)290601(10)14045738
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: B33895
• Device Lot Number: 14045738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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