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	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Initial reporter full phone information: (b)(6).
Event or Problem Description
The complaint/event involved a 4-way high flow stopcock w/rotating luer.It was reported that the stopcocks started to leak during a patient's administration of an unspecified fluid and vasopressor medication.The leak was reportedly on the tubing at 'stopcock to stopcock' location.After the leak was identified, the tubing device was replaced.There was no visible cracks, the original connection was good, however, the device was leaking on the bed.There was no report of human harm associated with the complaint/event.
Additional Manufacturer Narrative
Received one used b4018 4-way high flow stopcock for inspection.There was a crack and crazing observed at the female luer.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, and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 15jul2024.

• 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: 19707469
• Report Number: 9617594-2024-00879
• Device Sequence Number: 18075948
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: 06/13/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/07/2024
• 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: UNSPECIFIED FLUID INFUSATE, MFR UNK.; UNSPECIFIED VASOPRESSOR MED/INFUSATE, MFR UNK.
• Patient Sex: Unknown