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	08/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that 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 generated a leaking filter.Registered nurse (rn) and nurse practitioner (np) stated this was the third one leaking for this patient.The medication leaking was tpn.There was patient involvement however, no harm was reported.

• 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: 17699104
• Report Number: 9617594-2023-00655
• Device Sequence Number: 15331050
• Product Code: FMG
• UDI-Device Identifier: 00887709008069
• UDI-Public: (01)00887709008069(17)280601(10)13683717
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/10/2023

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: 13683717
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TPN, UNK MFR.
• Patient Sex: Unknown