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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 side of the pressure bag split.The product fault occurred found while in use with patient.There was no medical intervention required.There was a patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: one sample was returned for investigation.Unit received with secondary labeling as required.Unit received had writing written in red marker on the bag material.Unit received with the side seal partially separated.Visual of unit noted the side seal was coming apart greater than 50% of the length of the seal and still attached at the top and bottom of the bag.Confirmed problem of seal separation as noted in complaint.Visual inspection of the returned unit was able to verify side seal had partially come apart.Sample was functionally tested by manually pumping assembly using hand squeeze bulb to 300mmhg.Prior to getting to 300mmhg a remaining portion of the side seal that was attached came apart.Clear cuff assembly are 100% leak tested prior to release; it appears the seal came apart after product was shipped during subsequent use.Reported problem caused during the rf seal operation during assembly.Corrective and preventative maintenance have occurred to the assembly machine after the production of lot number on complaint.No corrective actions are planned at this time.Icu medical regularly analyzes complaint data and trends and will take further actions accordingly.

• 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 ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19359117
• Report Number: 1526863-2024-00036
• Device Sequence Number: 17727766
• Product Code: KZD
• UDI-Device Identifier: 10351688507037
• UDI-Public: (01)10351688507037(17)330205(10)4373476
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: MX4705
• Device Lot Number: 4373476
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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
• Patient Race: Asian