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	Disconnection (1171); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The event involved a 4-way high flow stopcock w/rotating luer where it was reported stopcock luer lock only threads 1-1.5 rotations, with continuous movement of iv lines, the luer lock loosens itself because disconnected.This happened on a critical icu patient on route to ct scan, luer lock/stopcock for inotrope loosened and disconnected by itself and blood pressure started to crash.Haulting route to ct scan to stabilize patient, multiple professionals witnessed.Frequency of the problem was recurring.Impact of the problem was severe.There was patient involvement and there was patient harm.The adverse event was luer lock/stopcock disconnected by itself and blood pressure started to crash.Haulting route to ct scan to stabilize patient.The medication involved was vasopressor.There was no blood loss or bleed back.
Additional Manufacturer Narrative
One (1) photo was shared by the customer, where a new sealed sample item #b4018 is observed without physical damage or anomalies.One (1) opened/unused sample list #b4018 was returned for evaluation.As received no anomalies or damages were observed on the sample.The male luer and female luer of the sample were found within specification and the sample passed the spin collar retention test as well.No mating device was returned for evaluation.Complaint of disconnection / loose connection cannot be confirmed or replicated.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 18540324
• Report Number: 9617594-2024-00048
• Device Sequence Number: 7780120
• Product Code: FMG
• UDI-Device Identifier: 00887709008694
• UDI-Public: (01)00887709008694(17)281001(10)13797203
• 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): 02/22/2024

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: 13797203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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
• Patient Sex: Unknown