MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER,LARGE VOLUME,VAR CONCENTRATIO; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1770

Device Problems Disconnection (1171); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges that the water pick up tube comes off when under gas pressure.This results in no gas flow or nebulization to the patient.It was reported there was no patient injury or consequence.

Event Description

Customer complaint alleges that the water pick up tube comes off when under gas pressure.This results in no gas flow or nebulization to the patient.It was reported there was no patient injury or consequence.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the tubing was not assembled correctly.Based on the visual exam, the complaint was confirmed.The tubing was not assembled correctly.A non-conformance was opened to address this issue.

• Brand Name: HUDSON NEBULIZER,LARGE VOLUME,VAR CONCENTRATIO
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7847422
• MDR Text Key: 119340735
• Report Number: 3004365956-2018-00267
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

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 Catalogue Number: 1770
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.