MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,SHELFPAK

Catalog Number 031-28

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the product involved in the complaint could not be conducted since the device sample was not returned.No picture available for evaluation.Customer complaint cannot be confirmed due to the lack of a device sample to perform a proper investigation and determine the root cause.If the device sample becomes available this investigation will be updated with the evaluation results.A capa file #(b)(4) was opened to perform a further investigation into this issue (this capa is owned by (b)(6)).According to the capa investigation so far the root cause for the issue 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 (b)(6) 2016 forward is with the updated (b)(4) snap adaptor component.Capa (b)(4) is currently under effectiveness verification.

Event Description

Customer alleges that the adaptor could not connect with the oxygen flow meter.A new kit was opened.

Manufacturer Narrative

(b)(4).Additional information has been received by the sales rep and it was discovered that the product reported in the complaint was not a teleflex product, thus, this complaint was voided.Please void mdr#3004365956-2016-00300 that was submitted on 07/28/2016.

Event Description

Customer alleges that the adaptor could not connect with the oxygen flow meter.A new kit was opened.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028,SHELFPAK
• Type of Device: NEBULIZER
• 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: 5831260
• MDR Text Key: 50718736
• Report Number: 3004365956-2016-00300
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 031-28
• Device Lot Number: 74C1503424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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