MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" SMALLBORE TRIFUSE EXT SET; STOPCOCK, I.V. SET

Catalog Number	A1141
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified triset generated a leak during patient use.The reporter stated that they have multiple reports of leaking triset.The reporter stated that the tri-set leaking upon starting total parental nutrition (tpn) and lipids out of the red medport.The disposable device was saved.There was no patient harm reported.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
One used.List #a1141, was returned for evaluation.As returned no physical damage or anomalies were observed on the returned set, only tpn and lipids solution residual was observed.No mating device was returned for evaluation.The set was tested as per procedure and leak from the subassembly, clave® nano y-connector was observed.The sample was dissembled, and a damage/torn silicone seal condition was found.Complaint of leak can be confirmed.The probable of the puncture on seal is typical due to incompatible mating device during use, dfu states: the clave connector is compatible with luers with an internal diameter (id) between 0.062" and 0.110".The probable cause of the damage observed on the seal is unknown.A device history lot review of possible lot was performed and no anomalies, discrepancies and nonconformances were identified that might be related with the condition reported by customer.Updated information in sections: d1, d2, d4, g4, and h4.

• Brand Name: 9.5" SMALLBORE TRIFUSE EXT SET
• 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: 21735737
• Report Number: 9617594-2025-00610
• Device Sequence Number: 9002349
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: (01)00887709069343(17)291101(10)14196195
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/19/2025

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: A1141
• Device Lot Number: 14196195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TPN, UNK MFR.
• Patient Sex: Unknown