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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date 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 where the customer reported that they received a report from nicu that the product was leaking at the site near the arrow and was discarded.It was also stated that they had experienced 2 incidents of leaking manifolds at the bonded joint.There was unknown patient involvement, unknown human harm and unknown delay in therapy.
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.
Additional Manufacturer Narrative
D9 device returned: on 11 oct 2024.Investigation summary: one (1) used list# am6154, 10" was returned for evaluation.As received the tube was observed to be separated from adapter.No mating device was returned for evaluation.The sample was tested as per procedure and a no leaks were observed.The separated tube was analyzed through uv light and insufficient solvent was confirmed.Complaint of leaks cannot be confirmed or replicated.However, the probable cause of the tube separation was due to insufficient solvent applied, during manual process assembly in ensenada.A device history review could not be conducted because no lot number(s) was/were identified.

• 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: 20384874
• Report Number: 9617594-2024-01384
• Device Sequence Number: 6473147
• 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): 11/18/2024

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?: Yes
• 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: 10/21/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown