MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.89 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHEC; STOPCOCK, I.V. SET

Catalog Number	MC33687
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation but it has not yet been received.
Event or Problem Description
The event involved a 4" (10 cm) smallbore trifuse ext set w/3 microclave¿ clear, 2 check valve, 3 clamps (2 white, red), rotating luer where the customer reported that total parenteral nutrition (tpn) and smof were infusing through trifuse into coil to patient and it was noted that there was no smof in coil.Upon inspection by the customer, they noted smof was leaking from trifuse and none entering coil; the customer disconnected smof and made new lines and smof lumen noted to be crooked and not in proper position.The nurse flushed port of trifuse and it was noted to be leaking below microclave cap, and the microclave cap appears not be secured the same as the other lumens.The nurse noticed the leak within the hour of patient being connected to infusion as patient had coil extension tubing on and no smof was found in the coil extension tubing.Smof was infusing @7.5ml/h so nurse identified that leak was not noticeable until patient had more time connected to infusion and they promptly changed lines when leaking was noticed, and they continue to monitor for any signs of central line bloodstream infection (clabsi).The event happened at 2000h during infusion.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Device was received for evaluation 7/8/24.The microclave male luer was not fully inserted into the female luer of the check valve.The set was leak tested per product specifications.There was leakage from the incomplete insertion.The reported complaint of leakage can be confirmed due to an incomplete insertion during manual assembly in manufacturing.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 4" (10 CM) APPX 0.89 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 2 CHEC
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 27790 ; MX 27790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19559287
• Report Number: 9617594-2024-00777
• Device Sequence Number: 4734810
• Product Code: FMG
• UDI-Device Identifier: 00887709064362
• UDI-Public: 00887709064362
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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: MC33687
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: TPN AND SMOF. MFR UNK
• Patient Sex: Unknown