MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICROMIST NEBULIZER,W/IN-LINE NEBTEE VL

Catalog Number 41745

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual inspection of the product involved in the complaint was performed on a picture provided by the customer.A short metal tube with a rounded end can be observed.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A device history record review was conducted and showed that the product was assembled & inspected according to our specifications.The visual inspection test was performed on the picture provided the customer however only a short metal tube with a rounded end was observed.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this customer complaint.If the device sample becomes available at a later date this complaint will be updated.

Event Description

The customer alleges that the oxygen tubing is popping off at the ventilator connection.The patient's condition is reported as fine.

• Brand Name: HUDSON MICROMIST NEBULIZER,W/IN-LINE NEBTEE VL
• Type of Device: NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5937374
• MDR Text Key: 54268235
• Report Number: 3004365956-2016-00346
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/28/2021
• Device Catalogue Number: 41745
• Device Lot Number: 74D1601724
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• 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: DRAEGER C500 EVITA VENTILATOR