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

Model Number	1-7321-80
Medical Device Problem Codes	Material Integrity Problem (2978); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All information reasonably known as of 02 aug 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
Allowed no rotation al all and certainly not a 360 degree rotation.It kinked in the bend.It is too soft and it is prone to kinking.Incident occurred during pt use.
Event or Problem Description
Allowed no rotation al all and certainly not a 360 degree rotation.It kinked in the bend.It is too soft and it is prone to kinking.Incident occurred during pt use.
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 stated: "allowed no rotation at all and certainly not a 360-degree rotation.It kinked in the bend.It is too soft and prone to kinking." an investigation was conducted based on these reported issues.According to the complaint report there were no injury to the patient.The product was physically returned; however, the sample had been used, which prevented an evaluation due to biohazard concerns.As a result, the complaint could not be confirmed, and no root cause was identified.The complaint has been submitted to carb under escalation number (b)(4) for further review.Date entered information in carb (b)(6) 2024.This is the first complaint reported for part number 1-7321-80.There were no other reported complaints reported for part number 1-7321-80 during the same timeframe.We will continue to monitor trends during our periodic complaint review meetings.

• 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 AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, china 51917 0; CH 519170
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 19897970
• Report Number: 1314417-2024-00026
• Device Sequence Number: 17829324
• Product Code: BTR
• UDI-Device Identifier: 10889483009079
• UDI-Public: (01)10889483009079
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 1-7321-80
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 09/11/2024
• 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