MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; INTUBATION

Model Number	292004
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical intubation|portex cuff pressure monitoring pressure easy was unable to maintain cuff pressure.No patient adverse events reported.
Event or Problem Description
Investigation completed.
Additional Manufacturer Narrative
Investigation completed on a smiths medical intubation portex cuff pressure monitoring.Pressure easy complaint of unable to hold cuff pressure was not verified.The device was visually inspected with no abnormalities noted.The manufacturing process was reviewed, along with the ifu with reveals, device passed 100% prior to release.Functional testing done.And device was able to hold pressures.No fault could be established.

• Brand Name: MEDEX
• Common Device Name: INTUBATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 11935884
• Report Number: 3012307300-2021-05472
• Device Sequence Number: 4396131
• Product Code: BSK
• UDI-Device Identifier: 10351688517173
• UDI-Public: 10351688517173
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K833327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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: No Information
• Device Model Number: 292004
• Device Catalogue Number: 292004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Weight: 3