MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMALL BORE STOPCOCKS; STOPCOCK, I.V. SET

Catalog Number	MX5341LN
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562); Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: other; device not returned to manufacturer.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 during an injected scan, the white part of the "tap" detached, causing the iodine to spill onto the scan table.This caused a 3-4 minute delay in performing the diagnostic scan (hematoma on left lower limb).Adverse patient effects are unknown.
Additional Manufacturer Narrative
Date returned to mfg 2/5/2024.One decontaminated device was returned.Visual inspection under the microscope confirmed that the plug and body were separated and was not assembled correctly.Functional testing was not performed.There is no assignable root cause for the plug and body not being assembled correctly.No corrective actions will be performed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: SMALL BORE STOPCOCKS
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18488343
• Report Number: 1526863-2024-00001
• Device Sequence Number: 7057138
• Product Code: FMG
• UDI-Device Identifier: 10351688506771
• UDI-Public: 10351688506771
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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 Expiration Date: 07/25/2026
• Device Catalogue Number: MX5341LN
• Device Lot Number: 4421389
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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
• Patient Sex: Unknown