MAUDE Adverse Event Report: PARKER MEDICAL PARKER; ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.0MM

Model Number	I-PFHV-70
Medical Device Problem Codes	Deflation Problem (1149); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All information reasonably known as of 18 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
Confirmed inflating tube was disconnected.Description of complaint intubated for surgery on may 4 and admitted directly to hcu.The tracheal tube was fixed with a bite block and fixture, and an automatic cuff pressure gauge was also attached.On may 13, a cuff pressure alarm went off in the hcu, and the staff responded to the alarm , after which staff observed a pilot balloon falling onto the bed.We confirmed that the inflating tube had been disconnected.The area where uv glue was applied was within 1 cm of the tip.Could this be due to inadequate adhesion because the infrating tube was barely inserted during manufacturing?what is your company's opinion?.
Event or Problem Description
Confirmed inflating tube was disconnected.Description of complaint intubated for surgery on may 4 and admitted directly to hcu.The tracheal tube was fixed with a bite block and fixture, and an automatic cuff pressure gauge was also attached.On may 13, a cuff pressure alarm went off in the hcu, and the staff responded to the alarm , after which staff observed a pilot balloon falling onto the bed.We confirmed that the inflating tube had been disconnected.The area where uv glue was applied was within 1 cm of the tip.Could this be due to inadequate adhesion because the infrating tube was barely inserted during manufacturing?what is your company's opinion?.
Additional Manufacturer Narrative
All information reasonably known as of 18 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 "confirmed inflating tube was disconnected." the complaint investigation was performed based on the content of the issue reported.Based on the complaint report, the issue was discovered before use upon inspection and no impact or harm to patient was reported.The product was not returned.The customer provided evidence that substantiates the complaint.The complaint was confirmed.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 i-pfhv-70 for disconnected tubing.There were eleven (11) complaints reported for part number i-pfhv-70 during the same timeframe for other failure modes.We will continue to monitor trends during our periodic complaint review meetings.

• Brand Name: PARKER
• Common Device Name: ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.0MM
• Manufacturer (Section D): PARKER MEDICAL; 9457 s university blvd; pmb 331; highlands ranch CO 80126
• Manufacturer (Section G): WELL LEAD MEDICAL CO; c-4 jinhu industrial estate; hualong; panyu, guangzhou 51143 4; JA 511434
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 19563719
• Report Number: 3000219639-2024-00050
• Device Sequence Number: 14445500
• Product Code: BTR
• UDI-Device Identifier: 00607411952739
• UDI-Public: 00607411952739
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/18/2024

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: I-PFHV-70
• Device Catalogue Number: I-PFHV-70
• Device Lot Number: UNKNOWN
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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