MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. STANDARD BORE EXTENSION SET WITH MALE LUER LOCK.; TUBING, FLUID DELIVERY

Model Number MX452FL

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

It was reported that the item is not working correctly, blood keeps leaking out; there is no stopping mechanism.No additional information.

Manufacturer Narrative

Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Two boxes of mx452fl with (b)(4) pc each box were received.All (b)(4) pc of mx452fl were received unopened.The samples described on the complaint were not received.Ten units, five from each box, were tested per internal procedures.The tests performed were pull test, air test, and leak test.All units passed all tests per specification.Unable to reproduce the fault listed on the complaint description.No fault found with the device.The cause of the reported problem could not be determined.Review of dhr shows there were no non-conformances written during the manufacturing of the device.

• Brand Name: STANDARD BORE EXTENSION SET WITH MALE LUER LOCK.
• Type of Device: TUBING, FLUID DELIVERY
• 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: 13542053
• MDR Text Key: 285690169
• Report Number: 3012307300-2022-03265
• Device Sequence Number: 1
• Product Code: FPK
• UDI-Device Identifier: 10351688507273
• UDI-Public: 10351688507273
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX452FL
• Device Catalogue Number: MX452FL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1