MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/TEE

Catalog Number 1884

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned for evaluation.No photo available.A device history record review could not be conducted since the lot number was not provided.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 in the incident.Customer complaint cannot be confirmed based only on the information provided.Material from the production line was inspected and no issues were detected that can lead this customer complaint.If the device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the connector is detaching from the tubing resulting in a leak.No patient injury or harm reported.

Manufacturer Narrative

(b)(4).The lot number was originally reported by the customer as unknown; however, the sample received was from lot number 74h1501695.A device history record (dhr) review was performed on the lot number of the sample received and there were no issues found that could relate to the reported 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 our specifications.The customer returned (1) one unit of catalog number 1884 micro mist nebulizer w/tee for analysis.A visual exam was performed and no defects were observed.Functional testing was also performed and the connector did not disconnect from the tubing during the testing.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.

Event Description

The customer alleges that the connector is detaching from the tubing resulting in a leak.No patient injury or harm reported.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5399364
• MDR Text Key: 37141047
• Report Number: 3004365956-2016-00091
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

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: Health Professional
• Device Catalogue Number: 1884
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 01/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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