MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15 CM) APPX 0.48 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ (GLOW, RED, Y; STOPCOCK, I.V. SET

Catalog Number	B33392
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary received two (2) new list# b33392, 6" (15 cm) appx 0.48 ml, smallbore trifuse ext set w/3 microclave¿ (glow, red, yellow rings), 3 clamps, rotating luer for inspection.No physical defects or other anomalies observed.Both samples were primed in the direction of flow also checked for any backflow in the opposite direction.No leaking or backflow observed the returned new samples passed all subsequent functional tests.A dhr lot and relevant commodities were reviewed, the following discrepancy was identified: item b33392 2 pieces not in accordance with engineering drawing, with missing component r1-3248 when? 10/19/2022 where? area 5 cr2 night tune who? quality inspector claudia villegas #8037 quantity impacted and sampling results (fail/pass): 2 pieces of 120 reviewed are rejected, quantity of 335 is stopped" the reported complaint could not be confirmed.No used sample or mating device was returned for investigation.
Event or Problem Description
It was reported a 6" (15 cm) appx 0.48 ml, smallbore trifuse ext set w/3 microclave¿ (glow, red, yellow rings), 3 clamps, rotating luer with list number b33392 and lot number 10618760.The reporter stated that the 6" small bore trifuse ext set has malfunction multiple times on different patients.Noted to have back flowing of medication into other ports which caused the patient to receive no medication and have the mixing of the medication due to the backflow into other ports.The issue occurred while using the imaging intravenous (iv) pump together with the imaging power injector on 3 different occasions which caused a backflow of contrast going up the tubing into the main infusion line that was running continuously.The medication that was used was propofol.There was no harm to the patient reported.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.

• Brand Name: 6" (15 CM) APPX 0.48 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ (GLOW, RED, Y
• 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: 21511492
• Report Number: 9617594-2025-00395
• Device Sequence Number: 19981163
• Product Code: FMG
• UDI-Device Identifier: 00887709008182
• UDI-Public: (01)00887709008182(17)271001(10)10618760
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 04/28/2025

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: B33392
• Device Lot Number: 10618760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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: PROPOFOL, UNK MFR.
• Patient Sex: Unknown