MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, AN; STOPCOCK, I.V. SET

Catalog Number	A1134
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The event occurred on an unspecified date and involved 99" (251 cm) appx 6.8 ml, transfer set w/check valve, nanoclave® t-connector, anti-siphon valve, 0.2 micron filter, luer lock.It was reported that several tubing snaps at the one-way valve when the patient was receiving ivf.There was patient involvement, and no human harm reported as a consequence of this event.
Additional Manufacturer Narrative
A picture was returned showing the transfer set with the tubing broken off at the nano t-connector.The complaint of the tubing snapping at the one way valve can be confirmed based on the returned image.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, AN
• 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: 20008562
• Report Number: 9617594-2024-01162
• Device Sequence Number: 11855745
• Product Code: FMG
• UDI-Device Identifier: 00887709069077
• UDI-Public: (01)00887709069077(17)290101(10)13873971
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/19/2024

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: A1134
• Device Lot Number: 13873971
• 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: 07/23/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IVF, MFR UNK
• Patient Sex: Unknown