MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED; E/T TUBE CUFFED 7.0MM 28FR

Model Number	1-7333-70
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Fail to remain inflated, my understanding is that tube inflates but the valve is not holding.
Additional Manufacturer Narrative
All information reasonably known as of 20 june 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
Fail to remain inflated, my understanding is that tube inflates but the valve is not holding.
Additional Manufacturer Narrative
All information reasonably known as of 20 june 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 "fail to remain inflated, my understanding is that tube inflates but the valve is not holding." the complaint investigation was performed based on the content of the issue reported.Based on the complaint report no patient was affected as a result, the patient's airway would be compromised.There were no photo images or videos of the reported issue; therefore, the complaint was unable to be confirmed and no root cause was identified.Rm226962 was issued 5/21 and ups labels sent; however, the product has not been returned for evaluation as of july 10, 2024.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board." this is the first (1) complaint reported for part number 1-7333-70.There were no other reported complaints reported for part number 1-7333-70 during the same timeframe.We will continue to monitor trends during our periodic complaint review meetings.

• Brand Name: SUNMED
• Common Device Name: E/T TUBE CUFFED 7.0MM 28FR
• 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: 19578327
• Report Number: 1314417-2024-00025
• Device Sequence Number: 11802205
• Product Code: BTR
• UDI-Device Identifier: 10889483001806
• UDI-Public: (01)10889483001806
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 1-7333-70
• Device Catalogue Number: 1-7333-70
• Device Lot Number: 2306011372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/20/2024
• 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