MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" (25 CM) APPX 1.0 ML, SMALLBORE EXT SET W/6-PORT NANOCLAVE¿ MANIFOLD, CHECK V; STOPCOCK, I.V. SET

Catalog Number	AM6154
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional initial reporter phone number: (b)(6).The expiration and manufacturing dates are unknown, because the lot number is unknown.
Event or Problem Description
An event involving a 10" (25 cm) appx 1.0 ml, smallbore ext set w/6-port nanoclave¿ manifold, check valve (orange, glow, blue, purple, yellow, green rings), nanoclave¿, luer lock experienced leakage.It was stated that the nursing department / nicu received a report that the product was leaking at the site near the arrow, and was discarded.It was also stated that leaking occurred on nanoclave port.There was unknown patient involvement, unknown human harm and unknown delay in therapy.
Additional Manufacturer Narrative
A photo was provided showing a drawing of the configuration of the set with the area of leakage indicated.No product samples or videos of the used product were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record could not be reviewed due to the unknown lot number.Corrected information can be found in b5 and h6 component code.
Event or Problem Description
The complaint/event occurred on an unspecified date.

• Brand Name: 10" (25 CM) APPX 1.0 ML, SMALLBORE EXT SET W/6-PORT NANOCLAVE¿ MANIFOLD, CHECK V
• 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: 19956905
• Report Number: 9617594-2024-01122
• Device Sequence Number: 8810000
• Product Code: FMG
• UDI-Device Identifier: 00887709126886
• UDI-Public: 00887709126886
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/11/2025

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: AM6154
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 08/10/2024
• Supplement Report FDA Received Date: 03/11/2025
• 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 DRUG , MFR UNK.
• Patient Sex: Unknown