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

Model Number	MTF37
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the device was leaking from luer lock port, "cracks/shattering" of the male luer lock connector at the end.Cracking was occurring, during reconnection after a line disconnect.Visible cracks found after connecting, disconnecting and reconnecting port.Patient involvement unknown.
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 additional reportable information becomes available.
Event or Problem Description
Additional information was received confirming the item was broken during patient use, but the patient was not harmed.
Additional Manufacturer Narrative
Additional information: b5 and h6 - health impact codes.
Additional Manufacturer Narrative
Other, other text: h6.Evaluation codes: updated.D3, g1,2 email is: (b)(6).No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• 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: 17187048
• Report Number: 3012307300-2023-06560
• Device Sequence Number: 20456877
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2023

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: Health Professional
• Device Expiration Date: 02/13/2026
• Device Model Number: MTF37
• Device Catalogue Number: MTF37
• Device Lot Number: 4368886
• Was Device Available for Evaluation?: No
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 07/17/2023; 11/08/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/26/2023; 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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