MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15 CM) APPX .92 ML, BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOC; STOPCOCK, I.V. SET

Catalog Number	MC33419
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.Additional reporter information: (b)(6).
Event or Problem Description
The event involved a 6" (15 cm) appx.88 ml, bifuse ext set w/2 microclave¿ clear, 2 clamps, luer lock where it was reported leaking microclave through plastic of base.Patient was not properly sedated as a result.Medication leaking into bed instead of infusing properly into the patient.Medication involved was fentanyl and propofol.Patient has critical airway and was attempting to reach to endotracheal (et) tube.Leaking occurred through base of microclave and patient not receiving appropriate sedation.Patient agitated with critical airway and unable to settle until intravenous (iv) site changed.There was patient involvement and no adverse event.
Additional Manufacturer Narrative
Received one used list# mc33419, 6" (15 cm) appx.88 ml, bifuse ext set w/2 microclave¿ clear, 2 clamps, luer lock; lot# unknown.No visual damages or anomalies were observed.The reported complaint of a leak could not be confirmed.The returned sample was leak-tested and met product specifications.A dhr review could not be conducted because no lot number was identified.Corrected information can be found in h6 health effect impact code.

• Brand Name: 6" (15 CM) APPX .92 ML, BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOC
• 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: 20810608
• Report Number: 9617594-2024-01706
• Device Sequence Number: 21317523
• Product Code: FMG
• UDI-Device Identifier: 00887709038622
• UDI-Public: 00887709038622
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: MC33419
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 01/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FENTANLY, UNK MFR; PROPOFOL, UNK MFR
• Patient Sex: Unknown