MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, Y; STOPCOCK, I.V. SET

Catalog Number	AM6128
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional contact: (b)(6).The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
Event occurred regarding smallbore extension set w/ 6-port nanoclave manifold where it was reported that the patient was on medications.Rn was checking the patient when she felt the mattress was wet.Rn picked up the manifold, and one of the ports cracked off completely.Patient's blood pressure and heart rate had dropped significantly, and they had to push emergency medications.Patient is currently stable again.The product was used roughly 4-8 hours.There was patient harm and there was delay in therapy.
Additional Manufacturer Narrative
One used device was returned for investigation.The device was visually inspected.The housing was broken from the manifold on the nanoclave.Examination of the break showed one side higher than the other and the weld still intact.The reported complaint can be confirmed.The probable cause is due to an unintentional bending force during use.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.D9 - date returned to mfg: 11/18/2025.

• Brand Name: 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, Y
• 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: 23632933
• Report Number: 9617594-2025-02211
• Device Sequence Number: 18475968
• Product Code: FMG
• UDI-Device Identifier: 00887709086968
• UDI-Public: 00887709086968
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: AM6128
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/06/2026
• 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: EPINEPHRINE, MFR UNKNOW.; INSULIN, MFR UNKNOWN; MILRINONE, MFR UNKNOWN; PHENYLEPHRINE, UNKNOWN MFR; VASOPRESSIN, MFR UNKNOWN
• Patient Sex: Unknown