MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER; VENTILATOR, EMERGENCY, MANUAL

Model Number	IPN039351
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint reported that: "during the inspection, the nursing area indicate that the mask was broken".No report of patient harm/injury.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Complaint reported that: "during the inspection, the nursing area indicate that the mask was broken".No report of patient harm/injury.
Additional Manufacturer Narrative
(b)(4).The samples were returned and sent to the manufacturer (galemed) for investigation.Galemed reports "the broken cracks are all at the clamping line of the products, and the cracks are relatively smooth, no burr.All mask must be test the leakage in produce process.Obviously, if the crack is so large, it cannot pass the leakage test." the conclusion of manufacturer is as follows: "according the above information and returned sample, we speculate that the operator did not use the correct method to remove burrs from the product during the manufacturing process.As a result, the welding strength of the product at this position is reduced.However, there was no immediate crack in the production process, so the leak test in the plant was qualified.In the process of transportation, the product may be subjected to large vibration or impact, resulting in deterioration or damage of this position.".

• Brand Name: HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER
• Common Device Name: VENTILATOR, EMERGENCY, MANUAL
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15145222
• Report Number: 3011137372-2022-00143
• Device Sequence Number: 5234628
• Product Code: BTM
• UDI-Device Identifier: 14026704662682
• UDI-Public: 14026704662682
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K964719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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
• Device Expiration Date: 03/29/2024
• Device Model Number: IPN039351
• Device Catalogue Number: 5372
• Device Lot Number: 210329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 09/13/2022
• 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
• Patient Sex: Unknown