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 Codes	Inflation Problem (1310); Gas/Air Leak (2946); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device 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 was unable to inflate pressure into the cuff.The pressure gauze does not show pressure reading due to a leak.A second device was used and the pressure decreased after blowing the air for just a few minutes.The event occurred while in use with patient.The issue was resolved by using a new one.There was patient involvement, and no patient harm/adverse event reported.Total 2 devices were affected.
Additional Manufacturer Narrative
D9: 1/16/2025.G1: corrected.H6: evaluation codes updated.Device evaluation: two samples of two different lot numbers were received for evaluation.Samples were visually and functionally tested and both were found to be leaking, confirming the customer reported complaint.The cause of the leak was found to be from the manufacturing process of solvent bonding of tubing to luer connection.No adverse trends have been identified related to these reported issues.No corrective actions are planned at this time.No causes or potential causes for the customer's reported problem were found during the dhr reviews.

• 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: 21150012
• Report Number: 1526863-2025-00001
• Device Sequence Number: 13070586
• Product Code: KZD
• UDI-Device Identifier: 50351688507011
• UDI-Public: (01)50351688507011(17)330926(10)4422308
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 4422308
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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