MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS,; STOPCOCK, I.V. SET

Catalog Number	MC3316
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.(b)(6).
Event or Problem Description
The event involved a 7" (18 cm) approximately 0.37 ml, smallbore bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer where it was reported the y site on total parenteral nutrition (tpn) line snapped and tpn became contaminated.The impact of the incident was having to pause tpn and delaying nutritional needs.There was unexpected or prolonged care.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
Corrected information can be found in h6 health effect - impact code.
Additional Manufacturer Narrative
A photo was provided by the customer that shows the separated line.Received one used partial mc3316 smallbore bifuse ext set.The separated tubing was examined under uv light and showed sufficient solvent coverage.The tubing was measured and found to meet dimensional specifications.The reported complaint can be confirmed.The probable cause is unknown.A device history record was not conducted because the lot number was unknown.Corrected information can be found in e4 - initial report sent to fda and h6 component codes.
Event or Problem Description
Additional information was received on 05-jun-2025 providing a possible lot number 4039557903.

• Brand Name: 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS,
• 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: 22340679
• Report Number: 9617594-2025-01352
• Device Sequence Number: 9160608
• Product Code: FMG
• UDI-Device Identifier: 00887709037458
• UDI-Public: 00887709037458
• 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,Followup
• Report Date (Section B): 08/08/2025

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: MC3316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 07/11/2025; 07/11/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/08/2025; 08/08/2025
• 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: TPN, UNK MFR.
• Patient Sex: Unknown