MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30 CM (12") APPX 3.2 ML, SET PER INFUSIONE, 4 CLAVE® CONNECTOR, FILTRO; STOPCOCK, I.V. SET

Catalog Number	011-H1268
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.A review of the device history record and the approval of this complaint investigation is pending.D4, g4: model number is not sold in the us but similar device is sold under model number mc330712.Mc330712 was used for the di and 501k.
Event or Problem Description
The complaint/event involved a 30 cm (12") appx 3.2 ml, set per infusione, 4 clave® connector, filtro.It was reported that the luer lock access routes of the trees detached from the tubing when unspecified chemotherapy bags were already assembled.The nurses noticed this incident when the administration of the chemotherapy bags had started.There was no report of any human harm.
Additional Manufacturer Narrative
No 011-h1268 product samples, videos, or photographs were returned for investigation.A probable cause cannot be identified based on the information that has been provided.The device history review (dhr) for lot 13911862 was reviewed and there were no non-conformances found that would have contributed to the reported complaint.

• Brand Name: 30 CM (12") APPX 3.2 ML, SET PER INFUSIONE, 4 CLAVE® CONNECTOR, FILTRO
• 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: 19998937
• Report Number: 9617594-2024-01149
• Device Sequence Number: 19919267
• Product Code: FMG
• UDI-Device Identifier: 00887709126800
• UDI-Public: 00887709126800
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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-H1268
• Device Lot Number: 13911862
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 08/18/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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: UNSPECIFIED CHEMOTHERAPY INFUSION BAGS, MFR UNK.
• Patient Sex: Unknown