MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED; PREFORMED ORAL CUFFED E/T TUBE 8MM 32FR

Model Number	1-7321-80
Medical Device Problem Code	Ventilation Problem in Device Environment (3027)
Health Effect - Clinical Code	Sore Throat (2396)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): e/t tube.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 22 nov 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by sunmed holdings llc.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 sunmed holdings llc.Sunmed holdings llc.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 sunmed holdings complaint database and is 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 a sunmed holdings llc.Product is defective or causes serious injury.
Event or Problem Description
"the tube twisted and kinked on itself during the insertion.  quote from the anesthesiologist: ""from what i recall he had a bit of a sore throat on waking up, but there was no further injury or intervention apart from reintubation.It was a near miss though for a hypoxemic arrest."" the patient desalted to 40% to which the tube was removed.".
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by sunmed holdings llc.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 sunmed holdings llc.Sunmed holdings llc.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 sunmed holdings complaint database and is 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 a sunmed holdings llc.Product is defective or causes serious injury.Complaint was considered confirmed based on customer narrative of events.A 24 month review was conducted and 1 additional complaints were identified related to this issue however no trend was observed.The lot number was provided, and the vendor was notified of the incident.This incident was not identified as an increasing trend.No further action to be taken.
Event or Problem Description
"the tube twisted and kinked on itself during the insertion.Quote from the anesthesiologist: ""from what i recall he had a bit of a sore throat on waking up, but there was no further injury or intervention apart from reintubation.It was a near miss though for a hypoxemic arrest."" the patient desatted to 40% to which the tube was removed.".

• Brand Name: SUNMED
• Common Device Name: PREFORMED ORAL CUFFED E/T TUBE 8MM 32FR
• 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: 20763360
• Report Number: 1314417-2024-00030
• Device Sequence Number: 18248316
• Product Code: BTR
• UDI-Device Identifier: 10889483009079
• UDI-Public: (01)10889483009079(10)2310012358
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1-7321-80
• Device Catalogue Number: 1--7321-80
• Device Lot Number: 2310012358
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/30/2024
• 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