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

Catalog Number	MX4705
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pressure bag was leaking, the device was newly purchased and still unused.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H6: codes were updated.No device was received for investigation.Therefore, the reported complaint is unable to be confirmed.If the device is received, the investigation will be re-opened for further evaluations.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• 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 ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 23680570
• Report Number: 1526863-2025-00153
• Device Sequence Number: 9984274
• Product Code: KZD
• UDI-Device Identifier: 10351688507037
• UDI-Public: (01)10351688507037(17)341125(10)6070467
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: MX4705
• Device Lot Number: 6070467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 01/31/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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