MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VA; STOPCOCK, I.V. SET

Catalog Number	AM3127
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
Event or Problem Description
The event involved a 11" (28 cm) appx 1.1 ml, smallbore ext set w/3-port nanoclave¿ manifold, check valve, clave¿ clear, luer lock where it was reported that a port popped off of the manifold.This was attached to an umbilical venous catheter (uvc) and with this port opened it created a backflow of blood into the tubing and into the patient¿s bed.There were sure how many cc's of blood the patient lost but luckily it was caught relatively soon by the bedside rn.To the bedside rns knowledge, there was nothing manipulated the port for it to pop off.The product was used during use on the patient.Newly placed line, medication had not yet run through it.The medication used was 5% dextrose in water (d5%) from baxter.There was patient involvement, no patient harm but lost blood and luckily it was noticed quickly.There was delay in therapy since patient lost uvc access and had to obtain additional access due to this.
Additional Manufacturer Narrative
Two photos were provided showing the port with the nanoclave missing.Received one used am3127 and one new am3127 for inspection.The used sample had a nanoclave missing from the port.Examination of the area under uv light showed adhesive coverage.The other ports were evaluated for bond integrity per product specifications.Each sample passed.The uv coverage of the failed sample was comparable to the samples that passed the bond integrity testing.The reported complaint can be confirmed.The probable cause is unknown.Corrected information can be found throughout section e, h6 health effect - clinical code and h6 component codes.The lot history of possible lot number 5782880 was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VA
• 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: 22332672
• Report Number: 9617594-2025-01346
• Device Sequence Number: 9024574
• Product Code: FMG
• UDI-Device Identifier: 00887709122949
• UDI-Public: (01)00887709122949
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 08/18/2025

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: AM3127
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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: 5% DEXTROSE IN WATER (D5%), BAXTER.; UMBILICAL VENOUS CATHETER (UVC), MFR UNK.
• Patient Sex: Unknown