MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6-PORT NANOCLAVE® MANIFOLD (GLOW, RED, BLUE, PURPLE, YELLOW RINGS), CHECK VALVE,; STOPCOCK, I.V. SET

Catalog Number	AM6001
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.
Event or Problem Description
It was reported that a 6-port nanoclave® manifold (glow, red, blue, purple, yellow rings), check valve, rotating luer generated a leak during patient use.The reporter stated that there was a crack in the manifold causing a leak.There was no patient harm reported.
Additional Manufacturer Narrative
No am6001 product samples, videos, or photographs were returned for investigation.The dhr was not reviewed, and no lot number information was provided.A probable cause cannot be identified based on the information that has been provided.The device history review (dhr) was not reviewed, and no lot number information was provided.D9 - device available for evaluation: no.

• Brand Name: 6-PORT NANOCLAVE® MANIFOLD (GLOW, RED, BLUE, PURPLE, YELLOW RINGS), CHECK VALVE,
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20186182
• Report Number: 9617594-2024-01281
• Device Sequence Number: 20611268
• Product Code: FMG
• UDI-Device Identifier: 00887709067783
• UDI-Public: 00887709067783
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K080077
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: AM6001
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMIODARONE DRIP, UNK MFR; NICARDIPINE DRIP, UNK MFR; PLASMALYTE FLUIDS, UNK MFR
• Patient Sex: Unknown