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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a to 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 that experienced breakage during patient use.The reporter stated that when changing fluids and spiking pn bag, tubing (single lumen tpn tubing set) got faulty with one of the tubes breaking off.Then, neonatal nurse practitioner was contacted at 17:43 and was told to use new tubing for pn bag.Critical nurse was notified of incident, faulty tubing was delivered to the charge nurse office and collected by manager.The event date occurred on (b)(6) 2025 during patient use.Thus, there was patient involvement, no human harm and unknown delay in therapy reported.
Additional Manufacturer Narrative
Received one used a1134 transfer set for inspection.As received, the nano t-connector was broken.The area of the break was examined and found to have stress whitening on one side while the other side was higher.The reported complaint can be confirmed.The probable cause is due to an unintentional bending force during use.The device history recordreview could not be conducted because no lot number was identified.Corrected information can be found in d10.

• 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: 21931418
• Report Number: 9617594-2025-00861
• Device Sequence Number: 8714833
• Product Code: FMG
• UDI-Device Identifier: 00887709069077
• UDI-Public: 00887709069077
• 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): 06/06/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: UNSPECIFIED FLUIDS, MFR UNK; UNSPECIFIED PARENTERAL NUTRITION (PN), MFR UNK
• Patient Sex: Unknown