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

Catalog Number 031-33J

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received by the manufacturer for investigation 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 due the lack of device sample to perform a proper investigation and determine the root cause.Root cause is unknown.No corrective actions can be assigned at this time.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the user connected the adaptor to the flow meter but air leakage occurred during setup because the connecting part of flow meter and adaptor was unstable.".

Manufacturer Narrative

(b)(4).One (1) unit of subassembly ph12153 033 neb adaptor phantom holder was received for analysis.This subassembly is part of the 031-33j nebulizer adaptor 033, sterile, (b)(6), related to this customer complaint.Signs of use were observed, and it was observed that adaptor doesn't spin freely.The sample was functionally tested and during the setup of the oxygen entrainment test it was observed that the assembly of the nut adaptor and the upper body was unstable.Even with that condition, the sample was able to be tested but the testing failed.After the testing finished, the adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection it was found there was wear on the internal tabs.Based on the investigation performed the complaint is confirmed.Although the condition was observed on the sample provided, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The wear on the internal tabs of the adaptor was most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.

Event Description

Customer complaint alleges "the user connected the adaptor to the flow meter but air leakage occurred during setup because the connecting part of flow meter and adaptor was unstable.".

• 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: 7957804
• MDR Text Key: 123500316
• Report Number: 3004365956-2018-00291
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• 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: 10/15/2018
• Date Manufacturer Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOW METER; FLOW METER