MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX C FUSOR 500ML PRESSURE INFUSOR; INFUSOR, PRESSURE, FOR IV BAGS

Catalog Number	MX4805
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a discrepancy between the lot numbers printed on the labels and those on the actual products.The lot number on the box was 6015735 and the lot number on the product was 4262848.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.Investigation summary: product totaling eight units received for investigation in original packaging and appeared to be in unused condition.No testing performed.Performed visual evaluation and comparison of 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 mx4805p1 occurred in another icu medical location in the european union where the product was ce marked.The finished assembly was produced from subassemblies 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 mx4805 per approved procedure and added into dublin manufacturing inventory.No actions are being implemented as the finished assembly are identified as required, no problem identified.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: MEDEX C FUSOR 500ML PRESSURE INFUSOR
• Common Device Name: INFUSOR, PRESSURE, FOR IV BAGS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20739758
• Report Number: 1526863-2024-00093
• Device Sequence Number: 8755285
• Product Code: KZD
• UDI-Device Identifier: 50351688507011
• UDI-Public: (01)50351688507011(17)340619(10)6015735
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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: 6015735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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