MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS,; STOPCOCK, I.V. SET

Model Number	MC3316
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The event involved a 7" (18cm) appx 0.37ml, smallbore bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer.It was reported that the saline lock extension tubing connector piece (plastic) snapped off.According to the report ¿sedation became disconnected at some point.The patient woke up.Impact of incident was patient woke up, patient currently has spinal cord compression.Patient was not supposed to wake up.Could have harmed himself.There was unknown unexpected or prolonged care.There was no blood loss/bleed back reported.The product was used since patient was transferred to the unit ~26-36 hours.New tubing was attached and bolus of sedation was administered to re-sedate the patient.There was no report of any further patient harm.
Additional Manufacturer Narrative
Completion of the complaint investigation is pending.Attempts will be made to obtain further information from the customer (including attempts to obtain a sister sample device from the same lot number).Additional contact: safnaa dastoor -regulatory affairs associate ( the stevens company limited) 778-328-2802 safnaa.Dastoor@stevens.Ca.
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample or sister samples a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history record for lot 5757085 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS,
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16850436
• Report Number: 9617594-2023-00168
• Device Sequence Number: 12674619
• Product Code: FMG
• UDI-Device Identifier: 00887709037458
• UDI-Public: (01)00887709037458(17)261201(10)5757085
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MC3316
• Device Catalogue Number: MC3316
• Device Lot Number: 5757085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• 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 SEDATION, MFR UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown