MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" (23 CM) APPX 0.63 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, NANOCLA; STOPCOCK, I.V. SET

Catalog Number	A1062
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 9" (23 cm) appx 0.63 ml, smallbore bifuse ext set w/2 microclave® clear, nanoclave®, 3 clamps, 0.2 micron filter, rotating luer.Lipids were reportedly leaking after changing the fluids for a patient that had a central line running tpn and nutralipids.The leakage was observed soon after the tubing was primed.There was no adverse event.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
D9 - date returned to mfg on 10/8/2024.Received one used a1062 smallbore bifuse ext set for inspection.A crack was observed on the nano y-connector.The set was leak tested according to product specifications.There was leakage from the crack.The reported complaint of leakage can be confirmed due to the crack.The probable cause is due to an external force during use.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 9" (23 CM) APPX 0.63 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, NANOCLA
• 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: 20407769
• Report Number: 9617594-2024-01400
• Device Sequence Number: 3351944
• Product Code: FMG
• UDI-Device Identifier: 00887709052956
• UDI-Public: 00887709052956
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: A1062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NUTRALIPIDS, MFR UNK; TPN, MFR UNK
• Patient Sex: Unknown