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); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the device could not be conducted since the product or a picture of the defect was not provided at the time of this report.A device history record (dhr) review for the device lot number reported , shows that the device was assembled and inspected according to our specifications.According to the dhr, component p/n mp-0321 was used during assembly.Mp-0321 is the older design of the snap-on flowmeter adaptor, for which capa file #(b)(4) was opened.According to the capa investigation, the root cause for the issue reported was the positioning of the thread lead and the softness of the new resin used for the snap adaptor.Change order form for the design updated approved and dhf has been updated.All production from may 2016 forward is with the updated tfx-001743 snap adaptor component.Capa (b)(4) is currently closed.This customer complaint cannot be confirmed based only on the information received.In order to perform a proper investigation to confirm the alleged defect reported it is necessary to have to device sample.If the device becomes available at a later date, this report will be updated with the investigation results.

Event Description

Customer complaint from (b)(6) alleges "the user noticed that the thread of the snap-on connector was damaged prior to use on a patient." there was no report of patient harm.

Manufacturer Narrative

Qn#: (b)(4).The sample was received for evaluation.A visual exam was performed and it was observed that there was damage on the internal thread of the adaptor.This damage is not acceptable according to current specifications.Even with that condition, the sample was able to be tested on the dual station lift test and the general pull and push test procedures.However, it was not possible to perform the oxygen entrainment testing because the adaptor could not be connected properly on the oxygen supply due to the damage on the internal threads.Based on the investigation performed, the reported complaint was confirmed.The root cause for the issue was found to be the positioning of the thread lead and the softness of the new resin used for the snap adaptor.A capa was previously opened to address this issue.The design of the adaptor was updated.All production from may 2016 forward is with the updated snap adaptor component.

Event Description

Customer complaint from (b)(6) alleges "the user noticed that the thread of the snap-on connector was damaged prior to use on a patient".There was no report of patient harm.

• 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: 6823513
• MDR Text Key: 83851732
• Report Number: 3004365956-2017-00339
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/03/2020
• Device Catalogue Number: 031-28J
• Device Lot Number: 74F1500449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2015
• 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