MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE

Catalog Number 031-33J

Device Problem Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the device was not returned.No photo for review.The device history record of the product 031-33j batch number 74d1501883 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due to the lack of device sample to perform a proper investigation and determine the root cause.If the sample becomes available this investigation will be updated with the evaluation results.However, a capa file #(b)(4)was opened to perform a further investigation this issue (this capa is owned by (b)(4)).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.Additionally, the personnel of the assembly line were notified of this issue.

Event Description

The customer alleges that the adaptor does not connect to the oxygen flowmeter.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the sample was received without the puncture pin protector.It was also noticed that there was damage on the internal thread of the adaptor.The damage on the internal thread of the component is not acceptable according to the current specifications.Although the adaptor was damaged, the sample could be connected to the oxygen supply and the oxygen entrainment test was able to be performed.In addition, the dual station lift test was able to be performed and the sample met current specifications.Based on the visual exam, 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 opened to address this issue.

Event Description

The customer alleges that the adaptor does not connect to the oxygen flowmeter.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER ADAPTOR
• 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: 5273492
• MDR Text Key: 32892363
• Report Number: 3004365956-2015-00385
• 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: 11/30/2015

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 Expiration Date: 04/15/2020
• Device Catalogue Number: 031-33J
• Device Lot Number: 74D1501883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• 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