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

Model Number MTF37

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

It was reported that the leur lock is cracked and leaking.No additional information.

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
• Type of Device: 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
• MDR Text Key: 291395767
• Report Number: 3012307300-2022-08517
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10351688510327
• UDI-Public: 10351688510327
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K841882
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 07/15/2022
• 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