MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM

Catalog Number 41755

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device sample is available for evaluation at the time of this report.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 of batch number (b)(4) has been reviewed and no issues or discrepancies were found which could potentially related to this complaint.The dhr shows that the product was assembled & inspected according to our specifications.No corrective action can be established at this moment since the product sample is not available for evaluation.Physical sample is necessary in order to confirm the failure mode.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 on this complaint.If the device sample becomes available at a later date this complaint will be updated.

Event Description

The customer alleges that there is no nebulization of the medication.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was medicine residue inside the jar.Without removing the medicine residue from the nebulizer jar, the sample was placed in the nebulizer fixture and no mist was created.The medicine residue was then removed from the nebulizer jar, and it was tested according and found to be within specification.No issues were found than could lead to the condition reported by the customer.Based on the investigation performed, the reported complaint was confirmed.It was found that when the nebulizer was tested with medicine residue inside the jar, no mist was created.After the nebulizer was cleaned and the residue was removed, the device performed within specification and no issues were detected.It was determined that the root cause of the issue was user related.

Event Description

The customer alleges that there is no nebulization of the medication.

• Brand Name: HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM
• 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: 5945714
• MDR Text Key: 54537270
• Report Number: 3004365956-2016-00353
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2021
• Device Catalogue Number: 41755
• Device Lot Number: 74E1602520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2016
• 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