MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.54 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LO; STOPCOCK, I.V. SET

Catalog Number	MC33383
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; it has not been received.The investigation is pending.
Event or Problem Description
The event involved a 60" (152 cm) appx 0.54 ml, smallbore ext set w/microclave® clear, clamp, luer lock where the customer reported that the med line was leaking right in the middle of the clave.This was noticed when giving a prn ativan dose for a patient that is very difficult to sedate, med line was connected to a piv.The patient also has a double lumen cvl but the leaking medline was not attached to the cvl.The patient missed the ativan dose because it leaked on the floor, so a new ativan dose was administered.There was patient involvement, unknown patient harm and unknown delay in therapy.
Additional Manufacturer Narrative
The complaint of leaks on item mc33383 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.

• Brand Name: 60" (152 CM) APPX 0.54 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LO
• 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: 21114688
• Report Number: 9617594-2025-00044
• Device Sequence Number: 20701548
• Product Code: FMG
• UDI-Device Identifier: 00887709038295
• UDI-Public: (01)00887709038295
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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: MC33383
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ATIVAN, MFR UNK.
• Patient Sex: Unknown