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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
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.The reporter stated that, when the bedside rn's student attempted to push morphine at the top of the line, the bifuse was still clamped at the bottom.When the morphine was attempted to be pushed, it instead reportedly leaked out through the bottom of the clave at the top of the line and dripped onto the floor.The bedside rn checked that it was screwed on properly by the student, and it was.The entire iv line was disconnected, morphine was pulled back out of the line, and the remainder wasted.A new dose was obtained for the patient, and a new line was primed.There was no report of any human harm.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Additional contact: (b)(6).Hospital.
Additional Manufacturer Narrative
Investigation summary received one (1) used mc330428 smallbore ext set w/microclave connected to one (1) used list #unknown 1ml syringe for inspection.No defects or anomalies noted.Fluid was infused through the mc330428 with the returned 1ml syringe for inspection.There were no restrictions in flow.The set was leak tested per product specifications.There was no leakage.The reported complaint of leakage could not be confirmed.Three (3) photos were provided showing the microclave and syringe.No defects or anomalies noted.Received one (1) used mc330428 smallbore ext set w/microclave connected to one (1) used list #unknown 1ml syringe for inspection.No defects or anomalies noted.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: 22321763
• Report Number: 9617594-2025-01326
• Device Sequence Number: 18379533
• Product Code: FMG
• UDI-Device Identifier: 00887709088344
• UDI-Public: (01)00887709088344(17)300201(10)14295798
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: 14295798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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: MORPHINE, MFR UNK.; UNSPECIFIED IV LINE, MFR UNK.
• Patient Sex: Unknown