MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX CLEAR CUFF PRESSURE INFUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS

Catalog Number	MX4805
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 inflation bulb was disconnected from the stopcock.The event occurred during pre-test and it happened at the hospital.There was no patient harm or adverse event reported as a result of the event.
Additional Manufacturer Narrative
D9: 26-mar-2025.H3: one unit was received with tubing bond from luer attaching to the stopcock pulled loose.No visual evidence of additional damage noted on the returned unit.Visual inspection showed the tubing assembly was bonded during manufacturing due to the presence of solvent ring on the tubing remaining and the depth position.Functional testing was performed and the customer reported problem was duplicated.A device history review was performed, and no adverse trends have been identified related to this issue.

• Brand Name: MEDEX CLEAR CUFF PRESSURE INFUSOR
• Common Device Name: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21648981
• Report Number: 1526863-2025-00024
• Device Sequence Number: 9308936
• Product Code: KZD
• UDI-Device Identifier: 50351688507011
• UDI-Public: (01)50351688507011(17)221012(10)4330423
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: MX4805
• Device Lot Number: 4330423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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