MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 16" EXT SET, 4-WAY STOPCOCK, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B4010
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation-it has not been received.Additional contact information: (b)(6).
Event or Problem Description
The event involved a 16" ext set, 4-way stopcock, rotating luer where the customer reported that the tubing is coming disconnected from luer lock end of tubing.The problem was recurring.The impact of the problem was minor.There was unknown patient involvement and unknown patient harm.
Additional Manufacturer Narrative
Received one opened/unused #b4010 for evaluation.As received the tube came separated from the male luer adaptor.The parts were analyzed with uv light and insufficient solvent coverage on tube was confirmed.No additional damage or anomalies were confirmed.Complaint of disconnection / loose connection can be confirmed based on the physical sample evaluation.The probable cause was due to an insufficient solvent applied during manual process assembly at manufacturing.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 16" EXT SET, 4-WAY STOPCOCK, 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: 18070457
• Report Number: 9617594-2023-00939
• Device Sequence Number: 12666477
• Product Code: FMG
• UDI-Device Identifier: 00887709008656
• UDI-Public: (01)00887709008656(17)270601(10)6031700
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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: B4010
• Device Lot Number: 6031700
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/04/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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
• Patient Sex: Unknown