MAUDE Adverse Event Report: PARKER MEDICAL PARKER; PARKER TRACH VAC WITH FLEX-TIP AND PVC CUFF (H-PFTVVC), 7.0MM

Model Number	H-PFTCCV-70
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All information reasonably known as of 27 sept 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
The tube was intubated into the patient on (b)(6).On (b)(6), the ventilator was removed, and an attempt was made to extubate the patient, but the tube could not be removed.At that time, the tube could not be pushed in.Suspecting edema, a steroid was administered, and after a day of observation, another attempt was made on (b)(6), but the patient could not be extubated.On (b)(6), the surgeon was able to push the tube in.The anesthesiology department consulted with the surgeon and otolaryngology department, and on (b)(6), a tracheotomy was performed in the op room, and only the tip of the tube was removed from the tracheostomy site.In order to remove the tube tip, a larger incision was made than a normal tracheotomy.When the tube was removed, the patient was ventilated with the intubated tube up to the tracheostomy.From the tracheostomy, the end of the tube was first cut off, and only the end of the tube, including the cuff, was removed from the tracheostomy site.The tube could not be pushed in.,.
Additional Manufacturer Narrative
All information reasonably known as of 27 sept 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 complaint was considered confirmed based on customer narrative of events.A 24 month review was conducted and no additional complaints were identified related to this issue and 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.
Event or Problem Description
The tube was intubated into the patient on august 13.On august 19, the ventilator was removed, and an attempt was made to extubate the patient, but the tube could not be removed.At that time, the tube could not be pushed in.[?]suspecting edema, a steroid was administered, and after a day of observation, another attempt was made on august 20, but the patient could not be extubated.On august 21, the surgeon was able to push the tube in.The anesthesiology department consulted with the surgeon and otolaryngology department, and on august 22, a tracheotomy was performed in the op room, and only the tip of the tube was removed from the tracheostomy site.In order to remove the tube tip, a larger incision was made than a normal tracheotomy.When the tube was removed, the patient was ventilated with the intubated tube up to the tracheostomy.From the tracheostomy, the end of the tube was first cut off, and only the end of the tube, including the cuff, was removed from the tracheostomy site.The tube could not be pushed in.,.

• Brand Name: PARKER
• Common Device Name: PARKER TRACH VAC WITH FLEX-TIP AND PVC CUFF (H-PFTVVC), 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: 20328133
• Report Number: 3000219639-2024-00073
• Device Sequence Number: 15478577
• Product Code: BTR
• UDI-Device Identifier: 10749065191700
• UDI-Public: (01)10749065191700(10)2401STV0248K
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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-PFTCCV-70
• Device Catalogue Number: H-PFTVVC-70
• Device Lot Number: 2401STV0248K
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/08/2024
• 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