MAUDE Adverse Event Report: PARKER MEDICAL PARKER FLEX-TIP; PARKER ENDO-BRONCH WITH STANDARD TIP(LEFT DOUBLE-LUMEN ENDOBRONCHIAL TUBE),PSTDL

Model Number	H-PSTDL-35
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was de-intubated and re -intubated with another tube. .
Additional Manufacturer Narrative
The tip bending during intubation caused the patient to be de-intubated and re-intubated with another tube.
Additional Manufacturer Narrative
The tip bending during intubation caused the patient to be de-intubated and re-intubated with another tube.The complaint of "tip bent during intubation" regarding part i-pstdl-35 was confirmed via photo.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 7 complaints against the product in the past 24 months.0 of those complaints were regarding the tip bending.A resolution letter was sent to the customer.
Event or Problem Description
The patient was de-intubated and re -intubated with another tube. .
Additional Manufacturer Narrative
The tip bending during intubation caused the patient to be de-intubated and re-intubated with another tube.The complaint of "tip bent during intubation" regarding part i-pstdl-35 was confirmed via photo.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 (b)(4) complaints against the product in the past 24 months.0 of those complaints were regarding the tip bending.A resolution letter was sent to the customer.Udi related data quality updates only.
Event or Problem Description
The patient was de-intubated and re -intubated with another tube.

• Brand Name: PARKER FLEX-TIP
• Common Device Name: PARKER ENDO-BRONCH WITH STANDARD TIP(LEFT DOUBLE-LUMEN ENDOBRONCHIAL TUBE),PSTDL
• 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: 17914125
• Report Number: 3000219639-2023-00030
• Device Sequence Number: 6777216
• Product Code: CBI
• UDI-Device Identifier: 10749065851406
• UDI-Public: (01)10749065851406
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024
• 2 Devices were Involved in the Event: 1 2

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-PSTDL-35
• Device Catalogue Number: H-PSTDL-35
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 09/11/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/30/2023; 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: Other
• Patient Sex: Unknown