MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.31 ML, SMALLBORE 24 HOUR EXT SET W/REMV BRAVO24¿, CLAMP; STOPCOCK, I.V. SET

Catalog Number	SC9036
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three photographs were provided by the customer, unable to determine reported complaint from the photographs provided.The complaint of disconnection could not be confirmed on the four returned sc9036 microclave.Each device was visually examined, there were no damages or anomalies observed.The used sc9036 microclave sample was leak test per product specification.Activated each of the microclaves with an icu medical syringe, no stick downs observed.No leakage was observed in either the activated or unactivated positions.There was no disconnection noted during testing.The returned four used sc9036 microclaves met product specification.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9: device returned to manufacturer on 12/5/2024.
Event or Problem Description
The event occurred on an unspecified date and involved a 7" (18 cm) appx 0.31 ml, smallbore ext set w/remv microclave®, clamp, rotating luer.The reporter stated the device has a faulty stop valve.Saline was used and when an iv was started on the patient then the valve doesn't work.The customer stated that they "use the saline bags to draw up in 5cc syringes, they attach the tubing to use as saline flushes for iv¿s.Once an iv has been placed with the defective tubing blood leaks from the iv and we are no longer able to inject through the tubing.Because of this, we have either had to disconnect the tubing and switch for another or restart the iv completely, causing patient an unnecessary stick".There was patient involvement and no adverse event.

• Brand Name: 7" (18 CM) APPX 0.31 ML, SMALLBORE 24 HOUR EXT SET W/REMV BRAVO24¿, CLAMP
• 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: 21210433
• Report Number: 9617594-2025-00175
• Device Sequence Number: 15492940
• Product Code: FMG
• UDI-Device Identifier: 00887709040533
• UDI-Public: (01)00887709040533(17)290801(10)14120481
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 01/22/2025

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: SC9036
• Device Lot Number: 14120481
• 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: 12/27/2024
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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: SALINE, UNK MFR
• Patient Sex: Unknown