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

Model Number	H-PFST-75
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All information reasonably known as of 29 aug 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
During intubation, a leak was found.Scratches found on the cuff.
Additional Manufacturer Narrative
All information reasonably known as of 29 aug 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 10253.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.On july 31, 2024, well lead received the customer complaint from m c medical that the user declares that the cuff was leaked and damaged after intubation, but product has been passing the prior test before intubation.Well lead reviewed 3pcs retained samples of lot number 2111st2254l, no damage or leakage was found in retained samples, they all qualified.Well lead reviewed the dhr of lot number 2111st2254l, no abnormity was found in dhr.The results are as follows, 1.Man, the workers have been trained on the operation.2.Machine for the production process, we have conducted the validation, and the machines are qualified for manufacture.3.Material no change in the material of the cuff.The material has been validated by the use and testing.4.Method the staff work in accordance with sop.5.Environment the environment of the workshop is in the control of monitor.Well lead asked some questions to distributor (m c medical) for further investigation, the response as follows, 1.How long the product be used on patient? - immediately after intubation.I think it is about 1 minute after intubation.2.Did the physician use any device for intubation? - she or he was not using it 3.Did the patient have any sharp thing in mouth may cause the cuff leakage? - she or he was not using it.We have 100% inspection of the leakage in workshop and the cuff has passed the prior test before intubation, so we could not determine the root cause for this case is caused by product itself based on available information and above investigation.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board.This is the first (1) complaint reported for part number i-pfst-75-10.There were no other reported complaints reported for part number i-pfst-75-10 during the same timeframe.We will continue to monitor trends during our periodic complaint review meetings.
Event or Problem Description
During intubation, a leak was found.Scratches found on the cuff. .

• Brand Name: PARKER
• 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: 20103279
• Report Number: 3000219639-2024-00066
• Device Sequence Number: 12655139
• Product Code: BTR
• UDI-Device Identifier: 00607411959288
• UDI-Public: (01)00607411959288(10)2111ST2254L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984528
• 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): 08/29/2024

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-75
• Device Catalogue Number: H-PFST-75
• Device Lot Number: 2111ST2254L
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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