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

Model Number	MX452FL
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the item is not working correctly, blood keeps leaking out; there is no stopping mechanism.No additional information.
Additional 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.
• Common Device Name: 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: 13541847
• Report Number: 3012307300-2022-03217
• Device Sequence Number: 3684744
• Product Code: FPK
• UDI-Device Identifier: 10351688507273
• UDI-Public: 10351688507273
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown