MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX STOPCOCKS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MX9311L
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Stroke/CVA (1770); Loss of consciousness (2418)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other text: g5: 510k is blank, device is exempt.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the stopcock attached to the proximal port of a central venous catheter cvc being used for central venous pressure cvp monitoring became disconnected while the patient was transferred to the commode resulting in the patient passing out and requiring intubation.There was no loss of pulse however, the patient was later diagnosed with a stroke as a result of a venous air embolus.The original intended procedure was the central venous pressure monitoring post cardiac surgery.
Additional Manufacturer Narrative
Additional information is provided for h.2 and h.6.No product was returned.If the product is returned this complaint will be reopened for further investigation.Device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.D.4 full udi number: (b)(4).

• Brand Name: MEDEX STOPCOCKS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17655949
• Report Number: 3012307300-2023-08557
• Device Sequence Number: 20650352
• Product Code: FMG
• UDI-Device Identifier: 10351688504180
• UDI-Public: 10351688504180
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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 Expiration Date: 03/07/2025
• Device Catalogue Number: MX9311L
• Device Lot Number: 4259404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White