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	Gas/Air Leak (2946)
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 there was leakage on pressure the infusor.The product fault occurred found while in use with patient.There was no medical intervention required and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: two assemblies returned for investigation.Units received with secondary labeling as required.Both units received have writing written in red marker and have green label tags with "leakage" written on it pointing to area suspected of leakage.Under 10x magnification, each unit was noted to have a rf seal that had come apart approximately 3 inches from side seal allowing a leak channel.Visual inspection of the unit was able to verify leak channel on returned assemblies.Functional test by manually pumping assembly using hand bulb assembly confirmed leakage at the visible point where seal 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.The reported problem of air leakage as noted in the complaint has been confirmed due to rf seal that has come apart.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The complaint fault has been escalated to address a full root cause investigation.

• 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: 19358854
• Report Number: 1526863-2024-00035
• Device Sequence Number: 11694448
• Product Code: KZD
• UDI-Device Identifier: 10351688507037
• UDI-Public: (01)10351688507037(17)330205(10)4373476
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: 06/25/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/24/2024
• 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