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

Model Number	MTF37
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported, that the device was leaking from the luer lock port, cracks or shattering of the male luer lock connector at the end.The cracking occured, during reconnection after a line disconnect.Visible cracks found after connecting, disconnecting, reconnecting port.No patient harm reported.
Additional Manufacturer Narrative
Two (2) used device outside its original package were received.Both devices were visually inspected.Adaptor bifurcated on both devices were observed stressed and cracked, as the components exhibited white marks around the component confirming the complaint.A root cause was possible mishandling during use, as force is required to break the devices.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No actions taken however, the issue will be monitored for threshold or escalation.

• Brand Name: MEDEX EXTENSION SETS MULTI LINE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17157896
• Report Number: 3012307300-2023-06286
• Device Sequence Number: 14957793
• Product Code: FPA
• UDI-Device Identifier: 10351688510327
• UDI-Public: 10351688510327
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K841882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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
• Operator of Device: Other
• Device Expiration Date: 02/13/2026
• Device Model Number: MTF37
• Device Catalogue Number: MTF37
• Device Lot Number: 4368886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 07/22/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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