MAUDE Adverse Event Report: PARKER MEDICAL PARKER FLEX-TIP; PARKER FLEX-TIP TRACHEAL TUBE WITH STYLET, HIGH VOLUME LOW PRESSURE, CUFFED

Model Number	H-PFST-65
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): endotracheal tube.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 25 oct 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by sunmed holdings llc.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 sunmed holdings llc.Sunmed holdings llc.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 sunmed holdings complaint database and is 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 a sunmed holdings llc.Product is defective or causes serious injury.
Event or Problem Description
(b)(6)-japan_it was reported that the incident was discovered during patient use, there was a hole in the body of the tracheal tube.
Event or Problem Description
(b)(6).It was reported that the incident was discovered during patient use, there was a hole in the body of the tracheal tube.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): endotracheal tube.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 25 oct 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by sunmed holdings llc.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 sunmed holdings llc.Sunmed holdings llc.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 sunmed holdings complaint database and is 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 a sunmed holdings llc.Product is defective or causes serious injury.Complaint was considered confirmed based on customer narrative of events.A 24 month review was conducted and 1 additional complaint was identified related to this issue however no trend was observed.The lot number was provided, and the vendor was notified of the incident.This incident was not identified as an increasing trend.No further action to be taken.

• Brand Name: PARKER FLEX-TIP
• Common Device Name: PARKER FLEX-TIP TRACHEAL TUBE WITH STYLET, HIGH VOLUME LOW PRESSURE, CUFFED
• 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: 20539429
• Report Number: 3000219639-2024-00103
• Device Sequence Number: 18213830
• Product Code: BTR
• UDI-Device Identifier: 10749065801654
• UDI-Public: (01)10749065801654(10)2404ST0789J
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: H-PFST-65
• Device Catalogue Number: H-PFST-65
• Device Lot Number: 2404ST0789J
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/19/2024
• 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