MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, RO; STOPCOCK, I.V. SET

Catalog Number	B33098
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
Event or Problem Description
The event involved a 4" (10 cm) appx 0.40 ml, smallbore trifuse ext set w/3 microclave¿, 3 clamps, rotating luer where the customer reported that they are having the luer triple sets disconnecting from cvl claves.Other products involved at the time of event were mc100 and b3300.The product was in use for few hours when disconnection was observed.There was patient involvement, no human harm or adverse event, and unknown delay in therapy.
Event or Problem Description
Additional information was received stating that there were no issues noted on the icu med mating devices, mc100 and b3300.
Additional Manufacturer Narrative
Additional information b5 section.
Additional Manufacturer Narrative
One new and one used samples #b33098 with one microclave were returned for evaluation on 4/11/24.As received no physical damage or anomalies were observed.The male luer slip retention test were performed to the used and the new sample and the results were within specifications and met the iso design specification.Complaint of disconenection / loose cannot be confirmed or replicated.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
Additional information was received on 23 april 2024.A medsun mandatory medwatch report (mdr report #: mw5153673) which stated ¿there have been a few occurrences of trifuses spontaneously disconnecting from claves on patients' cvl tubing.The clear circular end has a prong that inserts into a blue clave and then the clear circular part twists onto the clave to keep it secure.However, the clear circular part round.The prong seems to be stripped or is not threading appropriately when trying to twist it into the clave.This is resulting in the prong popping out and the triple set disconnecting from the cvl without touching.¿.

• Brand Name: 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, RO
• 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: 19087757
• Report Number: 9617594-2024-00405
• Device Sequence Number: 20618358
• Product Code: FMG
• UDI-Device Identifier: 00887709006263
• UDI-Public: (01)00887709006263(17)281201(10)13856229
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2024

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: B33098
• Device Lot Number: 13856229
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 04/10/2024; 04/23/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 04/12/2024; 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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: B3300, ICU MEDICAL, INC; MC100, ICU MEDICAL, INC
• Patient Sex: Unknown