MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-28J

Device Problems Device Damaged Prior to Use (2284); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2018

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.The device history record (dhr) of the product has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.It is necessary to have the physical sample in order to perform a proper and thorough investigation to confirm the alleged defect, determine a root cause and establish any corresponding corrective actions.Customer complaint cannot be confirmed based on the information provided.Root cause is unknown.No corrective actions can be established at this time.If the device becomes available at a later date, this report will be updated with the evaluation results.

Event Description

Customer complaint alleges ther thread of the nut adapter was found damaged while connecting to the flow meter.Alleged defect reported prior to patient use.It was reported there was no patient involvement.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and damage on the thread of the adaptor was observed.The sample was tested on the dual station lift test and general pull and push test procedures with no functional issues.However, 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 on oxygen entrainment testing but the testing failed.Based on the functional testing of the sample received, the complaint is confirmed.Although the complaint is confirmed, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The damage found on the thread of the adaptor was most likely caused by the end user during the connection of the adaptor into the flowmeter causing an unstable connection.However, the personnel of the assembly line were notified on may-07-2018 for awareness.

Event Description

Customer complaint alleges ther thread of the nut adapter was found damaged while connecting to the flow meter.Alleged defect reported prior to patient use.It was reported there was no patient involvement.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• 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: 7397227
• MDR Text Key: 104538038
• Report Number: 3004365956-2018-00097
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/14/2022
• Device Catalogue Number: 031-28J
• Device Lot Number: 74A1701640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• 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