MAUDE Adverse Event Report: WELL LEAD MEDICAL CO. LTD REDITUBE¿ TRACHEAL TUBE ORAL/NASAL WITH PRELOADED STYLET; BASIC ENDOTRACHEAL TUBE, SINGLE-USE

Model Number	ET TUBE W/ STYLET, CUFFED SIZE 7
Medical Device Problem Codes	Deflation Problem (1149); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the 8070rtc - et tube w/ stylet, cuffed size 7 would not hold air in balloon for a spine procedure.A decision was made to flip the patient supine and reintubate with a new ett (endotracheal tube).The cuff was checked prior to intubation for loss of air, and none was present but a small hole in the balloon cuff was found.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.

• Brand Name: REDITUBE¿ TRACHEAL TUBE ORAL/NASAL WITH PRELOADED STYLET
• Common Device Name: BASIC ENDOTRACHEAL TUBE, SINGLE-USE
• Manufacturer (Section D): WELL LEAD MEDICAL CO. LTD; c-4 jinhu industrial estate hu; along, pan yu guangzhou guangd; hualong,guangzhou guangdong ; CH
• Manufacturer (Section G): WELL LEAD MEDICAL CO., LTD; no. 47 guomao avenue south pan; yu guangzhou guangdong, china; guangzhou guangdong 51143 4; CH 511434
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 15978308
• Report Number: 8030673-2022-00285
• Device Sequence Number: 7224734
• Product Code: BTR
• UDI-Device Identifier: 10190752148758
• UDI-Public: (01)10190752148758(10)22A016703K
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2022

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: ET TUBE W/ STYLET, CUFFED SIZE 7
• Device Catalogue Number: 8070RTC
• Device Lot Number: 22A016703K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 12/14/2022
• 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: Required Intervention
• Patient Sex: Unknown