MAUDE Adverse Event Report: TELEFLEX HUDSON MICRO MIST NEBULIZER W/TEE, TBG AND MTHPC; SMALL VOLUME NEBULIZER

Catalog Number 1883

Device Problem Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the liquid was not supplied to the pt.

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 dhr (device history record) was reviewed and showed that there were no issues related to this issue on the product nor its components during the mfr of the material.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 issue that can lead to the reported defect and no issues were found.If the device sample becomes available this investigation will be updated with the eval results.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE, TBG AND MTHPC
• Type of Device: SMALL VOLUME NEBULIZER
• Manufacturer (Section D): TELEFLEX; rtp NC
• Manufacturer Contact: margie burton, rn - reg affairs ; durham, NC 27709 ; 9194334965
• MDR Report Key: 4054327
• MDR Text Key: 17572200
• Report Number: 3004365956-2014-00322
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/29/2014

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: Other
• Device Catalogue Number: 1883
• Device Lot Number: 02B1300584
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1