MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13 CM (5") APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	011-H1836
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a 13 cm (5") appx 0.33 ml, smallbore bifuse ext set w/2 microclave¿, rotating luer lock where it was reported the "parts seperated and fell off" resulting in bleed back.This causes an embolism risk and infection risk to the patient due to the lines attached to sit in the patient¿s heart.There was patient involvement and unknown harm.
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.D4, g4: model number is not sold in the us but similar device is sold under model 011-c3322.This product was used for the di and 501k.(b)(6).
Additional Manufacturer Narrative
Investigation summary: a photo was provided showing the packaging information.There were no defects or anomalies noted.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history review was reviewed and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 13 CM (5") APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿, ROTATING LUER
• 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: 20048741
• Report Number: 9617594-2024-01180
• Device Sequence Number: 7959596
• Product Code: FMG
• UDI-Device Identifier: 00840619001742
• UDI-Public: (01)00840619001742(17)281201(10)13842727
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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: 011-H1836
• Device Lot Number: 13842727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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
• Patient Sex: Unknown