MAUDE Adverse Event Report: ICU MEDICAL, INC. MEDEX STANDARD SMALL-BORE T-CONNECTOR EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MX453
Medical Device Problem Codes	Partial Blockage (1065); Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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
It was reported that the device broke when pushing medications through it.The user was not pushing at a fast rate; there was regular pressure going into a spinal needle.There was unknown patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
G1 - mfg contact office address 1, g1 - mfg contact office city, g1 - contact office region state and g1 - contact office zip code: correction.D3 - mfg establishment name and h6.Codes: updated.Device evaluation: no physical sample was returned.One (1) photo provided for evaluation and confirmed the complaint of breaks when pushing medication thru, the photo confirms tubing disconnect.The potential cause was unable to be determined.The lot history review could not be completed because no verifiable lot number was identified or available in the system records.

• Brand Name: MEDEX STANDARD SMALL-BORE T-CONNECTOR EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 21294210
• Report Number: 1526863-2025-00006
• Device Sequence Number: 18441308
• Product Code: FPA
• UDI-Device Identifier: 10351688507259
• UDI-Public: (01)10351688507259(17)270818(10)6050655
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K790408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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 Catalogue Number: MX453
• Device Lot Number: 6050655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown