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	02/01/2025
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 unspecified date, a 99" (251 cm) appx 6.8 ml, transfer set w/check valve, nanoclave t-connector, anti-siphon valve, 0.2 micron filter, luer lock broke during patient use.The reporter stated that the parenteral nutrition (pn) tubing line broke while changing the syringe.It did not come into contact with the patient or healthcare provided and there was no chemo.It was stated that the line was changed and there was no chemo spill.The event occurred during patient use and no one was harmed as a result of the event.The event was noted during the changing of the syringe, to refill.There was no blood loss or bleed back.The filter was not replaced and therapy was not resumed.The saline was not replaced.There was no hole, cut, tears, or any defect noted before the breakage.
Additional Manufacturer Narrative
Received five used a1134 transfer sets and two used partial a1134 transfer sets for inspection.A break was observed on each sample around the nanoclave t-connector or the adaptor connected to the nanoclave.The break areas were examined, and each was found to have plastic deformation with stress whitening on one side and one side being higher than the other.The reported complaint can be confirmed.The probable cause is due to an unintentional bending force during use.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: 21569261
• Report Number: 9617594-2025-00444
• Device Sequence Number: 8226200
• Product Code: FMG
• UDI-Device Identifier: 00887709069077
• UDI-Public: (01)00887709069077(17)291201(10)14234736
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: A1134
• Device Lot Number: 14234736
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2024
• 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