MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/TEE; SMALL VOLUME NEBULIZER

Catalog Number 1737

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2013

Event Type  malfunction  

Event Description

The complaint was reported as: the customer alleges that the green stem on the bottom of the nebulizer breaks off.Nebulizer replaced with another one.No report of a pt injury or delay in treatment.

Manufacturer Narrative

A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The lot number was not provided, therefore it is not possible to determine in which condition this material was manufactured.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation, it is necessary to evaluate the sample involved on the incident.The customer complaint cannot be confirmed based only on the info provided, in order to perform a proper investigation, it is necessary to evaluate the sample involved on the incident.However current production was verified to identify any issues that can lead to the reported defect and no issues were found.If the defective sample becomes available, this investigation will be updated with the eval results.

• Brand Name: HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/TEE
• Type of Device: SMALL VOLUME NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas ; MX
• Manufacturer (Section G): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, ra clinical spec ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3769228
• MDR Text Key: 4438027
• Report Number: 3004365956-2014-00017
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1737
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2013
• 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