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	AM6100
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 aug 2025 has been used as a placeholder.The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
Event occurred on an unspecified date regarding a 10" smallbore ext set w/6-port nanoclave® manifold (orange, red, blue, purple, yellow rings), check valve, clamp, rotating luer where it was reported that "there is cracking and causing it to leak at the connection between manifold and extension set." there was unknown patient involvement and unknown human harm.
Additional Manufacturer Narrative
Investigation summary received six (6) used am6100 smallbore ext set for inspection.An incomplete insertion was observed at the female luer to male luer bond at the end of the manifold on each set.Each set was leak tested per product specifications.There was leakage from the incomplete insertions.The reported complaint can be confirmed.The probable cause is due to an incomplete insertion during manual assembly in the assembly plant.A device history record review could not be conducted because no lot number(s) was/were identified.Corrective and preventative actions are in process.

• 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: 23043379
• Report Number: 9617594-2025-01850
• Device Sequence Number: 9832443
• Product Code: FMG
• UDI-Device Identifier: 00887709070660
• UDI-Public: 00887709070660
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: AM6100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/28/2025
• 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
• Patient Sex: Unknown