MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number	MC3302
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) photograph was provided by the customer that confirms the complaint of leaking.Received one (1) used list# mc3302, 7" (18 cm) appx 0.24 ml, smallbore ext set w/microclave¿ clear, clamp, rotating luer; lot# unknown as received, there was some seal propagation along the top seal.Also, some residuals inside the clave body are indicative of a leak.The microclave silicone seal and spike were found damaged.The customer complaint of leaking can be confirmed.The tearing found in the silicone seal would cause the microclave to leak.The damage found to both spike and silicone is typical of the use of an incompatible mating device with the microclave.The dfu calls out microclave connectors are compatible with iso male luers having an internal diameter between 0.062" and 0.110".A device history review (dhr) lot# review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
The event involved a 7" (18 cm) appx 0.24 ml, smallbore ext set w/microclave¿ clear, clamp, rotating luer.It was reported iv (intravenous) was found leaking iv fluid in bed.Looked at connections and found that the small bore ext set w/microclave clear (mc3302) was where the leaking was coming from.The rubber stopper must have been broken as fluid was pooling behind the rubber part.Part immediately changed out.It was the connection to the nicu peripherally inserted central catheter (picc).There was patient involvement and no adverse event.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.Additional reporter: the stevens company limited (b)(6).

• Brand Name: 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING
• 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: 21190595
• Report Number: 9617594-2025-00142
• Device Sequence Number: 8640057
• Product Code: FMG
• UDI-Device Identifier: 00887709037267
• UDI-Public: 00887709037267
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: MC3302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 03/06/2025
• 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: IV FLUID, UNK MFR
• Patient Sex: Unknown