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
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.D4: only di provided as lot number is unknown.
Event or Problem Description
The event occurred on an unspecified date and involved 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 it was reported from the neonatal intensive care unit (nicu) that the product was leaking at the site near the arrow and was discarded.It was also stated that there was leaking manifolds at the green port.There was unknown patient involvement, unknown human harm and unknown delay in therapy.This report captures 2 occurrences.
Additional Manufacturer Narrative
D9: device returned: 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 leak from the adaptor and the subassembly nanoclave manifold bond was observed, no additional leaks along the set were observed.The separated tube was analyzed through uv light and insufficient solvent was confirmed.Complaint of leaks can be confirmed based on the physical used sample evaluation.The probable cause is due to an incomplete insertion during manual process assembly at ensenada.The probable cause of the separated tube was due to insufficient solvent applied on tube, during manual process assembly in ensenada.A dhr lot# 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20385571
• Report Number: 9617594-2024-01387
• Device Sequence Number: 8066192
• 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: 11/18/2024
• 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