MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 118" (300 CM) APPX 9.3 ML, TRANSFER SET W/ANTI-SIPHON VALVE, 3-WAY STOPCOCK, 2 M; STOPCOCK, I.V. SET

Catalog Number	B33381
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
Event or Problem Description
The event involved a 118" (300 cm) appx 9.3 ml, transfer set w/anti-siphon valve, 3-way stopcock, 2 microclave®, 0.2 micron filter, luer lock where the customer reported leaking on 4 sets during patient use.There was patient involvement, no patient harm, no adverse events and unknown delay in therapy.
Additional Manufacturer Narrative
The reported complaint of a leak could not be confirmed.The returned sample sets were tested and performed as expected.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 118" (300 CM) APPX 9.3 ML, TRANSFER SET W/ANTI-SIPHON VALVE, 3-WAY STOPCOCK, 2 M
• 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: 19342342
• Report Number: 9617594-2024-00618
• Device Sequence Number: 21017704
• Product Code: FMG
• UDI-Device Identifier: 00887709008069
• UDI-Public: (01)00887709008069(17)280901(10)13750287
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/02/2024

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 Catalogue Number: B33381
• Device Lot Number: 13750287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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
• Patient Sex: Unknown