MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER W/TEE,MTHPC & TBG, SMALL V

Catalog Number 41892

Device Problems Leak/Splash (1354); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2015

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.The device history record (dhr) of batch number (b)(4), product code 41892 has been reviewed and no issues or discrepancies were found related to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.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.If device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the nebulizer doesn't fit together.There is a leakage between the upper part and the down part of the nebulizer.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.Functional testing was also performed and no issues were detected.The unit was found to be within specification.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found during the visual exam and functional testing.Also, in order to duplicate the failure mode reported by the customer, additional testing was done on the sample; however, no defects were found that could be related to this complaint.As a preventive measure, a notification of the complaint was given to the personnel involved in the manufacturing process of the product, as well as re-training on the work instruction.

Event Description

The customer alleges that the nebulizer doesn't fit together.There is a leakage between the upper part and the down part of the nebulizer.

Manufacturer Narrative

(b)(4).The device history record of batch number 74g1402407 was reviewed and it was noticed that a non-conformance #60023803 was issued to the batch of this complaint but it is not related to the failure mode reported by the customer.

Event Description

The customer alleges that the nebulizer doesn't fit together.There is a leakage between the upper part and the down part of the nebulizer.

• Brand Name: HUDSON NEBULIZER W/TEE,MTHPC & TBG, SMALL V
• 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: 5144287
• MDR Text Key: 28040261
• Report Number: 3004365956-2015-00310
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 41892
• Device Lot Number: 74G1402407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2014
• 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