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

Catalog Number 031-33J

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided 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 product sample to perform a proper investigation to confirm the alleged defect, and determine the root cause.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the connection between the adaptor and the aquatherm heater was loose, so the adaptor soon detached from the heater.Therefore, a new unit was used instead.".

Manufacturer Narrative

(b)(4).Sample was received without its original packaging, in a (b)(6) bag with a disinfection tag.Visual inspection on the internal thread of component adaptor (tfx-001743) revealed signs of stress at the beginning of the thread.Functional inspection was conducted.The unit was connected to the oxygen station getting as a result an unstable connection.Then by applying a small amount of pressure towards the back of the nebulizer the lower part of the nebulizer got disconnected from the adaptor (txf-001743).An unused adaptor (txf-001743) was placed in the nebulizer in order to connect the unit back again to the oxygen station.No problem was found.An attempt to duplicate the failure mode reported was done with an unused adaptor and the actual complaint unit.(cont.) other remarks: failure mode was replicated by overtightening the adaptor to the oxygen station.A visual inspection of this adaptor showed the same stress marks condition at the tabs.Based on the investigation performed, the reported complaint is confirmed.However, based on the analysis of the sample received, there is not enough evidence to assure that this failure mode originated during the manufacturing and/or molding process.The stress marks observed on the internal tabs of adaptor (tfx-001743) were caused more likely by the end user while connecting the adaptor into the flowmeter causing an unstable connection therefore causing the unit to fall.Teleflex will continue to monitor customer feedback for complaints of this nature.Personnel of the assembly line were notified for awareness.

Event Description

Customer complaint alleges "the connection between the adaptor and the aquatherm heater was loose, so the adaptor soon detached from the heater.Therefore, a new unit was used instead.".

• 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: 7615399
• MDR Text Key: 111676728
• Report Number: 3004365956-2018-00201
• 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: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• 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: 07/16/2018
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AQUATHERM HEATER; AQUATHERM HEATER