MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX C-FUSOR PRESSURE INFUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number	MX4805
Medical Device Problem Codes	Fracture (1260); Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510k number is unknown, no product information has been provided.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
Per anvisa notification: during the development of their activities it was reported that a health professional observed air leakage from the faucet connection and when removing it, there were cracks and/or broken parts.The patient was in icu treatment.No patient injury.Additional information received by email on (b)(6) 2023, reporting that this lot is no longer available in stock.
Additional Manufacturer Narrative
Additional information: d4 - expiration date and h4 - manufacture date.H6 - evaluation codes: updated.Device evacuation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: MEDEX C-FUSOR PRESSURE INFUSOR
• Common Device Name: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17054826
• Report Number: 3012307300-2023-06017
• Device Sequence Number: 12455423
• Product Code: KZD
• UDI-Device Identifier: 50351688507011
• UDI-Public: 50351688507011
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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 Model Number: MX4805
• Device Catalogue Number: MX4805
• Device Lot Number: 4027716
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown