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 Codes	Crack (1135); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
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 an air leak and could not be pressurized normally.The air leak was alleged to be in one of the cracks underneath.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.Under 10x magnification, unit was noted to have a rf seal that had came apart approximately 3 inches from side seal allowing a leak channel.Investigation photos are available that show the rf seal leak point.Functional test was done by manually pumping assembly using hand bulb assembly which confirmed leakage at the visible point where the seal came apart.The reported problem was caused during the rf seal assembly operation.It appears that the seal came apart after product was shipped during subsequent use.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.Capa-0008063 was opened post lot# listed for investigation and any preventative and corrective actions.

• 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: 19488655
• Report Number: 1526863-2024-00046
• Device Sequence Number: 7164502
• Product Code: KZD
• UDI-Device Identifier: 10351688507037
• UDI-Public: (01)10351688507037(17)321118(10)4353480
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: 4353480
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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