MAUDE Adverse Event Report: PARKER MEDICAL PARKER FLEX-TIP; ENDOTRACHEAL TUBE, PREFORMED NASAL, HIGH VOLUME LOW PRESSURE, CUFFED (PFNC), PAR

Model Number	H-PFNC-65,H-PFNC-70
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Interruption in therapy caused the patient to be re-intubated.Patient involvement as the inflation tube falling out could cause hypoxia.The ifu instructs users to test for proper inflation of the cuff prior to intubation and this is a common practice in an intubation procedure.
Event or Problem Description
Cuffs are leaking. .
Additional Manufacturer Narrative
Interruption in therapy caused the patient to be re-intubated.Patient involvement as the inflation tube falling out could cause hypoxia.The ifu instructs users to test for proper inflation of the cuff prior to intubation and this is a common practice in an intubation procedure.The complaint of leaking cuffs regarding parts i-pfnc-65 and i-pfnc-70 was confirmed via photos.The samples were returned but had to be discarded due to contamination.The root cause cannot be determined but could possibly be a result of the cuff having a pin hole in it.A risk assessment was performed using rma-20024b, rev 1 and the severity rating was determined to be 6/10 which does not require the initiation of a capa.There have been 4 complaints against h/i-pfnc in the past 24 months.All 4 of those complaints were regarding leaks.A resolution letter was sent to the customer.
Event or Problem Description
Cuffs are leaking. .
Additional Manufacturer Narrative
Interruption in therapy caused the patient to be re-intubated.Patient involvement as the inflation tube falling out could cause hypoxia.The ifu instructs users to test for proper inflation of the cuff prior to intubation and this is a common practice in an intubation procedure.The complaint of leaking cuffs regarding parts i-pfnc-65 and i-pfnc-70 was confirmed via photos.The samples were returned but had to be discarded due to contamination.The root cause cannot be determined but could possibly be a result of the cuff having a pin hole in it.A risk assessment was performed using rma-20024b, rev 1 and the severity rating was determined to be 6/10 which does not require the initiation of a capa.There have been 4 complaints against h/i-pfnc in the past 24 months.All (b)(4) of those complaints were regarding leaks.A resolution letter was sent to the customer.Udi related data quality updates only.
Event or Problem Description
Cuffs are leaking.

• Brand Name: PARKER FLEX-TIP
• Common Device Name: ENDOTRACHEAL TUBE, PREFORMED NASAL, HIGH VOLUME LOW PRESSURE, CUFFED (PFNC), PAR
• 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: 17935631
• Report Number: 3000219639-2023-00031
• Device Sequence Number: 20420739
• Product Code: BTR
• UDI-Device Identifier: 10749065031655
• UDI-Public: (01)10749065031655(10)2203NC0480K,(01)10749065031709(10)2206NC1425J
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,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-PFNC-65,H-PFNC-70
• Device Catalogue Number: H-PFNC-65,H-PFNC-70
• Device Lot Number: 2203NC0480K, 2206NC1425J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 09/13/2023; 09/13/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 12/04/2023; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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