MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1734

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint reported as: there was a leakage at the level of the connector.This happened during the ventilation (whilst connected to the respiratory) and modifying the way it was tightened did not change anything in the leakage.The only way to solve the issue is to change the device.Clinical consequences: there was no consequence for the patient.Device was changed.There was no disruption to ventilation.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no issues were encountered.The device history record of batch number 74d1902778 that belongs to catalog number 1734 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on the investigaiton performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The unit functioned as intended.

Event Description

Customer complaint reported as: there was a leakage at the level of the connector.This happened during the ventilation (whilst connected to the respiratory).And modifying the way it was tightened did not change anything in the leakage.The only way to solve the issue is to change the device.Clinical consequences: there was no consequence for the patient.Device was changed.There was no disruption to ventilation.

• Brand Name: HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10077594
• MDR Text Key: 196933749
• Report Number: 3004365956-2020-00112
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K760489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

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 Operator: No Information
• Device Expiration Date: 04/25/2024
• Device Catalogue Number: 1734
• Device Lot Number: 74D1902778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.