MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 20" (51 CM) APPX 1.9 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, 2 6-PORT NANOCLAVE¿; STOPCOCK, I.V. SET

Catalog Number	AM6152
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint of leakage between the two sets of manifolds could not be confirmed.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A lot history review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
It was reported that a 20" (51 cm) appx 1.9 ml, ext set, smallbore w/clave¿ clear, 2 6-port nanoclave¿ manifolds, 2 check valves, spin luer generated a leak during patient use.It was reported that the leak was in the tubing between the two sets of manifolds.The sample impacted was discarded and not available for return.There was a patient involvement and no harm/adverse event was reported.

• Brand Name: 20" (51 CM) APPX 1.9 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, 2 6-PORT NANOCLAVE¿
• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19822581
• Report Number: 9617594-2024-00937
• Device Sequence Number: 8589505
• Product Code: FMG
• UDI-Device Identifier: 00887709122420
• UDI-Public: (01)00887709122420
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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: AM6152
• 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: 06/26/2024
• Initial Report FDA Received Date: 07/24/2024
• 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