MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON RESUS NEO MANOMETER AND MASK; VENTILATOR, EMERGENCY, MANUAL

Catalog Number 45372

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "the issue we found with the previous stock was that the mask deflates over time and cannot be re-inflated this makes the bag unusable".

Manufacturer Narrative

(b)(4).The analysis received from the manufacturing site (galemed) reports: 1.) check the production information of the customer complaint batch (lot# 201207 & 210215), there is no related abnormal records; 2.) the customer's sample cannot be sent back due to local control, and the photos provided are too vague for more specific analysis.3.) all mask must be test the leakage in produce process.Obviously, if the crack is so large, it cannot pass the leakage test; 4.) according with the information share by customer and the configuration of the material in the box didn't correspond to cracking so large when the package is opened."it was also reported, "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.Galemed has reported that corrective actions have been taken.

Event Description

It was reported that: "the issue we found with the previous stock was that the mask deflates over time and cannot be re-inflated this makes the bag unusable".The issue was detected prior to use on a patient during inspection/functional testing.

• Brand Name: HUDSON RESUS NEO MANOMETER AND MASK
• Type of Device: 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: 15447400
• MDR Text Key: 306163134
• Report Number: 3011137372-2022-00182
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: KE
• PMA/PMN Number: K964719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/07/2023
• Device Catalogue Number: 45372
• Device Lot Number: 201207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.