MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX SMALL BORE EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MTF37
Medical Device Problem Codes	Crack (1135); 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 leur lock is cracked and leaking.No additional information.
Additional Manufacturer Narrative
Other, other text: no lot number was provided; therefore, device history record review could not be performed.Two (2) product samples were received for evaluation.Visual inspection was performed.Visual inspection found the samples were stressed, as the part exhibited white marks around the components.The root cause of the reported issue was found to be that it could not be attributable to the manufacturing site; the most likely cause of the condition observed on returned samples indicate a possible mishandling during use, as force is required to break the devices.

• Brand Name: MEDEX SMALL BORE EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14357420
• Report Number: 3012307300-2022-08517
• Device Sequence Number: 19869242
• Product Code: FPA
• UDI-Device Identifier: 10351688510327
• UDI-Public: 10351688510327
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K841882
• 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): 07/15/2022

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: MTF37
• Device Catalogue Number: MTF37
• 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: 04/14/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 07/15/2022
• 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