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

Catalog Number	MX4810
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
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 lot number indicated on the outside of the product box does not match the lot number on the items inside.The event occurred upon opening.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6.Codes: updated.Device evaluation: no product was returned.Performed visual evaluation of the pictures provided and compared the lot number on the box label and lot number printed on the assemblies.Finished assembly are identified as required with lot number traceability, no problem identified.Completed assembly of the finished device as a mx4810p1 occurred in another icu medical location in the european union where the product was ce marked.The finished assembly was produced from subassemblies(a4810) provided from the dublin, ohio manufacturing site, these subassemblies have their own lot number identification applied during production.The product was pulled from the eu market as part of a ce re-classification project with all remaining inventory from the distribution center sent back to the dublin, ohio manufacturing site to be repackaged as mx4810 per approved procedure and added into dublin manufacturing inventory.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 INFUSION
• 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: 21020009
• Report Number: 1526863-2024-00112
• Device Sequence Number: 17173902
• Product Code: KZD
• UDI-Device Identifier: 50351688507004
• UDI-Public: (01)50351688507004(17)320524(10)6025032
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: MX4810
• Device Lot Number: 6025032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2022
• 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