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	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one used mc33687 smallbore trifuse ext set w/3 microclave for inspection.No damages or anomalies noted.The set was leak tested per product specifications.There was a leak from the bond area from the tubing to the adaptor on one of the lines.A bond integrity test was conducted and the bond failed product specifications.The reported complaint of leakage can be confirmed.The probable cause is due to a manual bonding error in manufacturing.
Event or Problem Description
The event involved a 4" (10 cm) appx 0.89 ml, smallbore trifuse ext set w/3 microclave¿ clear, 2 check valve, 3 clamps (2 white, red), rotating luer.It was reported that patient was connected to lines at 2140h and around 2150h they noticed bed being wet underneath the lines.Noticed leaking within 10 mins of patient being connected to total parenteral nutrition (tpn) and smoflipid.The infusion was stopped by the nurse and replaced the entire trifuse with new lines.There was a patient involved and unknown human harm.

• 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: 20075903
• Report Number: 9617594-2024-01207
• Device Sequence Number: 11531888
• 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
• Report Date (Section B): 08/27/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 08/27/2024
• 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: SMOFLIPID, MFR UNK; TOTAL PARENTERAL NUTRITION (TPN), MFR UNK
• Patient Sex: Unknown