MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B4020
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.
Event or Problem Description
The event occurred on an unknown date involving a 3-way high flow stopcock w/rotating luer where the customer reported that the stop cock had a hole in the plastic, allowing for medication to escape the closed iv med administration system.While this occurred, a significant amount of blood backed out of the iv catheter therapy, and was not getting the sedative, and as a result woke up, posing harm to patient.It was further stated that the patient had medications infusing through a central line located in the right ij (internal jugular).Stopcocks were in place between each medication line that is infusing.Upon assessment, a stopcock had a crack and blood started to back flow from the patient.There was patient involvement and a delay in therapy.There was no adverse event.
Additional Manufacturer Narrative
The complaint of holes/cuts/torn on item b4020 cannot be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history report (dhr) for lot#13617861 was reviewed and no non conformities were found that would have led the reported condition on the complaint.

• Brand Name: 3-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: 18948138
• Report Number: 9617594-2024-00304
• Device Sequence Number: 7084420
• Product Code: FMG
• UDI-Device Identifier: 00887709008717
• UDI-Public: (01)00887709008717(17)280401(10)13617861
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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: B4020
• Device Lot Number: 13617861
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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 MEDICATION, MFR UNK
• Patient Sex: Unknown