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

Model Number MX5341L

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that the stopcock became easily unhooked, and when re-attached it popped off again.Patient was on pressors.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Additional information added.

Event Description

Additional information - facility address : (b)(6).

Manufacturer Narrative

Device evaluation: one unused sample from the same lot was returned for investigation.The complaint states that the product becomes easily unhooked and when re-attached, pops off again.The customer returned a product that was not the exact product that was causing problems.Upon review of the returned product, the defect could not be confirmed through testing the product.All connections securely fastened to the threads and locknut.A review of the device history record (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.A review of manufacturing equipment records was also conducted and no issues were noted that could have contributed to this event.

• 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: 16338072
• MDR Text Key: 309181919
• Report Number: 3012307300-2023-01084
• Device Sequence Number: 1
• Product Code: FMG
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2023

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
• Device Operator: Health Professional
• Device Model Number: MX5341L
• Device Catalogue Number: MX5341L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 02/16/2023; 04/10/2023
• Supplement Dates FDA Received: 03/09/2023; 04/12/2023
• 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