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

Model Number MX5341L

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

Operator of device unknown.No information has been provided to date.Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

It was reported that the male connector was only threading half a turn.There has been no report of patient involvement, no observable clinical symptoms, or a change in symptoms identified in the patient.

Manufacturer Narrative

Other text: d3, g1, and g2 email is: regulatory.Responses@icumed.Com.H6 - evaluation codes: updated.Device evaluation: no product sample and no pictures were provided; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.No lot number was provided, therefore no device history report (dhr) review could be completed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: SMALL BORE STOPCOCKS
• Type of Device: STOPCOCK I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16259357
• MDR Text Key: 308360681
• Report Number: 3012307300-2023-00717
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688506788
• UDI-Public: 10351688506788
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MX5341L
• Device Catalogue Number: MX5341L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1