MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE),; STOPCOCK, I.V. SET

Catalog Number	MC330428
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 71" (180 cm) appx 0.44 ml, smallbore ext set w/microclave® clear, clamp (blue), rotating luer where the reporter stated that upon disconnecting a med line from a bifuse attached to a patient's ped's picc, the line disconnected in an unusual way.Upon further inspection, part of the med line remained fused to the bifuse, the tubing and piece that screws onto the bifuse connector both detached.Basically, the med line somehow ended up in 3 pieces.There was patient involvement, there was no significant delay in therapy and no harm to the patient.
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
Additional Manufacturer Narrative
Received one used list# mc330428, 71" (180 cm) appx 0.44 ml, smallbore ext set w/microclave® clear, clamp (blue), rotating luer.One used list# unknown, bifurcated t adaptor.As received, the tubing was separated, visual inspection under uv light shows lack of sufficient adhesive.No other damage or anomalies observed.Confirmed customer complaint, part of the med line tubing and piece that screws onto the bifuse connector both detached.Probable cause, insufficient solvent during assembly.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE),
• 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: 21122724
• Report Number: 9617594-2025-00050
• Device Sequence Number: 12628373
• Product Code: FMG
• UDI-Device Identifier: 00887709088344
• UDI-Public: (01)00887709088344(17)290601(10)14032610
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 02/24/2025

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: MC330428
• Device Lot Number: 14032610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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