MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED; E/T TUBE CUFFED 2.5MM 10FR

Model Number	1-7333-25
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All information reasonably known as of (b)(6) 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.
Event or Problem Description
The area where the pilot balloon meets the tube is narrowed, so much that a suction catheter cannot be passed through causing safety concerns.
Event or Problem Description
The area where the pilot balloon meets the tube is narrowed, so much that a suction catheter cannot be passed through causing safety concerns.
Additional Manufacturer Narrative
All information reasonably known as of (b)(6) 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.The complaint reported "the area where the pilot balloon meets the tube is narrowed, so much that a suction catheter cannot be passed through causing safety concerns." the complaint investigation was performed based on the content of the issue reported.Based on the complaint report no patient was affected.There were no photo images, videos or returned sample of the reported issue; therefore, the complaint was unable to be confirmed.An inventory assessment was conducted for part number 1-7333-25.However, the inventory from the reported lot (2306011372) was not available; therefore, we selected inventory from a different lot for evaluation.Based on the results from the visual inspection performed at grand rapids, the results showed that the tube diameters were within normal parameters.The complaint history was reviewed for the 24 months before the complaint reporting date for part 1-7333-25.No complaints with similar issues were detected, this is the first reporting complaint for part number 1-7333-25.Per the risk assessment performed in the activity log, the risk determination (medium) indicates that the complaint needs to be submitted to the capa review board.Added to carb (b)(6) 2024.We will continue to monitor trends during our periodic complaint review meetings.

• Brand Name: SUNMED
• Common Device Name: E/T TUBE CUFFED 2.5MM 10FR
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 19543634
• Report Number: 1314417-2024-00024
• Device Sequence Number: 6730246
• Product Code: BTR
• UDI-Device Identifier: 10889483048108
• UDI-Public: (01)10889483048108
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K042683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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 Model Number: 1-7333-25
• Device Catalogue Number: 1-7333-25
• Device Lot Number: 2306011372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown