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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone has an additional phone (b)(6).Received two used b4018 4-way high flow stopcock connected to each other for inspection.At the connection of the male luer to the female luer there was a crack and crazing observed.The reported complaint of a crack and subsequent leakage can be confirmed.The probable cause is due to environmental stress cracking during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a 4-way high flow stopcock w/rotating luer.The report stated that there has a leaking and crack in product.The impact of the problem is serious.The frequency of problem was first time, and the location of sample was in their department.The customer stated that the fault occurred during infusion or while in use with patient.The leak¿s exact location on tubing was stopcock to stopcock.The infusing was fluid and medications, vasopressors.The tubing was replaced once the leak was identified.There were no visible cracks, and the connection was good, but it was leaking on the bed.There was patient involvement and there was no patient harm or adverse event.

• 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: 20081280
• Report Number: 9617594-2024-01219
• Device Sequence Number: 20723245
• 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
• Report Date (Section B): 08/27/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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: VASOPRESSORS, MFR UNK.
• Patient Sex: Unknown