MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.43 ML, SMALLBORE EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, LU; STOPCOCK, I.V. SET

Catalog Number	MC33424
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation; however, has not yet been received.
Event or Problem Description
The event involved a 60" (152 cm) appx 1.8 ml, smallbore ext set w/remv microclave® clear, clamp (blue), luer lock where it was reported that they had multiple issues of syringe tubing leaking at the microclave.The event occurred while providing patient care.Per the report, ¿rn primed new syringe medication line to give scheduled lasix.No leakage noted during prime.While hooking up the flush and pushing a tad, rn realized the tubing was leaking from the microclave.Microclave removed and flush hooked directly to tubing to see it was a microclave issue vs tubing issues, tubing continued to leak.Another syringe tubing was retrieved from bedside cart with same lot number (lot: 14063312), same issue noted.Everything appears fine when flushing with no pressure, but if there is any resistance on the line (ex.Clamped or infusing into a line with other fluids running) the tubing leaks at the microclave with a slow drip.Tubing removed and other syringe tubing retrieved from supply room with no problems noted.¿ there was patient involvement and no adverse event/patient harm.
Additional Manufacturer Narrative
Two (2) used list#: mc33563, 60" samples, and one 0.9% sodium chloride, usp 10ml syringe were returned for evaluation.As received a crack on each of the female luer were observed.No additional damage or anomalies were found.The samples were tested as procedure and a leaks from a crack on the female luer was confirmed.No additional damage or anomalies were observed.Complaint of leak can be confirmed or replicated.The probable cause is a molding vendor issue.The device history lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.Corrective actions are in process.D9 device returned to manufacturer on: 2/5/2025.

• Brand Name: 60" (152 CM) APPX 0.43 ML, SMALLBORE EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, LU
• 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 ; .; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21193196
• Report Number: 9617594-2025-00150
• Device Sequence Number: 3480169
• Product Code: FMG
• UDI-Device Identifier: 00887709038677
• UDI-Public: (01)00887709038677(17)290601(10)14063312
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/02/2025

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: MC33424
• Device Lot Number: 14063312
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LASIX, UNK MFR.
• Patient Sex: Unknown