MAUDE Adverse Event Report: PARKER MEDICAL PARKER FLEX-TIP; ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 6.5MM

Model Number	H-PFHV-65
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This was a delay in intubation and ventilation.
Event or Problem Description
Tubing got a kink right above the pilot balloon almost causing the patient to code due to not being able to ventilate.
Event or Problem Description
Tubing got a kink right above the pilot balloon almost causing the patient to code due to not being able to ventilate.
Additional Manufacturer Narrative
This was a delay in intubation and ventilation.The complaint of "tubing kink right above the pilot balloon" regarding part h-pfhv-65-10 was not confirmed.The root cause cannot be determined but could possibly be a result of the tubing thickness being too thin.A risk assessment was performed using rma-20024b, rev 1 and the severity rating was determined to be 7/10 which does not require the initiation of a capa.There have been 4 other complaints against h/i-pfhv-65 in the past 24 months.0 of those complaints were regarding tubing kinks.An inventory evaluation of this lot was completed but no non-conformances were found.A resolution letter was sent to the customer.
Additional Manufacturer Narrative
This was a delay in intubation and ventilation.The complaint of "tubing kink right above the pilot balloon" regarding part h-pfhv-65-10 was not confirmed.The root cause cannot be determined but could possibly be a result of the tubing thickness being too thin.A risk assessment was performed using rma-20024b, rev 1 and the severity rating was determined to be 7/10 which does not require the initiation of a capa.There have been 4 other complaints against h/i-pfhv-65 in the past 24 months.0 of those complaints were regarding tubing kinks.An inventory evaluation of this lot was completed but no non-conformances were found.A resolution letter was sent to the customer.**udi related data quality updates only**.
Event or Problem Description
Tubing got a kink right above the pilot balloon almost causing the patient to code due to not being able to ventilate.

• Brand Name: PARKER FLEX-TIP
• Common Device Name: ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 6.5MM
• 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 TX 51143 4; JA 511434
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18196865
• Report Number: 3000219639-2023-00040
• Device Sequence Number: 17743220
• Product Code: BTR
• UDI-Device Identifier: 10749065011657
• UDI-Public: (01)10749065011657(10)2304HV1Q47J
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

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: H-PFHV-65
• Device Catalogue Number: H-PFHV-65
• Device Lot Number: 2304HV1Q47J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 10/24/2023; 10/24/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 12/14/2023; 07/23/2024
• 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: Required Intervention
• Patient Sex: Unknown