MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-33J

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received for evaluation by the manufacturer at the time of this report.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed based on the information received.When the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "water was leaking and was running down the corrugated tube during use on a patient".No patient harm reported.Patient condition reported as fine.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.The sample was received with a sterile water bottle that is not part of the product.No other issues were found.During the setup of the oxygen entrainment test it was observed that the assembly of the nut adaptor and the upper body component was unstable.Even with that condition, the sample was able to be tested on the oxygen entrainment testing with satisfactory results.As an additional test the sample was tested on the oxygen entrainment test using a bottle of sterile water connected to the nebulizer adaptor in order to simulate the use of the customer.No issues were detected.Based on the investigation performed, the reported complaint could not be confirmed.The sample was found to be within functional specifications and no issues were found during testing.

Event Description

Customer complaint alleges "water was leaking and was running down the corrugated tube during use on a patient." no patient harm reported.Patient condition reported as fine.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8147199
• MDR Text Key: 130037193
• Report Number: 3004365956-2018-00348
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 031-33J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.