MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B4018
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.E1 initial reporter phone number: (b)(6).
Event or Problem Description
The event involved a 4-way high flow stopcock w/rotating luer where it was reported the stopcock was leaking.No obvious damage seen, and connection was tight.Stopcocks were changed immediately.It was reported that the leaking started hours after it was initiated and occurred during a propofol and fentanyl infusion.Patient woke up and almost pulled out endotracheal tube, was restless, had to receive a dose of midazolam while stopcock was replaced.There was patient involved and no patient harm reported.
Additional Manufacturer Narrative
Received one new list# b4018, 4-way high flow stopcock w/rotating luer; lot# 13781156.No physical defects or other anomalies noted.Without the used sample, we are unable to confirm the customer complaint of a stopcock leak or determine a root cause.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to manufacturer on 8/5/2024.

• Brand Name: 4-WAY HIGH FLOW STOPCOCK W/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: 19829239
• Report Number: 9617594-2024-00942
• Device Sequence Number: 20872972
• Product Code: FMG
• UDI-Device Identifier: 00887709008694
• UDI-Public: (01)00887709008694(17)281001(10)13781156
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080077
• 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): 09/05/2024

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: B4018
• Device Lot Number: 13781156
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: FENTANYL, UNK MFR; MIDAZOLAM, UNK MFR; PROPOFOL, UNK MFR
• Patient Sex: Unknown