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

Catalog Number 031-33J

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The sample was received by the manufacturer, but the investigation is incomplete at the time of this report.The device history record of the product 031-33j, batch number (b)(4) 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.All materials used during the assembly met current specifications.Dhr shows that the product was assembled and inspected according to our specifications.A capa file #(b)(4) was opened to perform a further investigation this issue (this capa is owned by r & d).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 on the assembly line will be notified and made aware of this issue.

Event Description

The customer alleges that the nebulizer adaptor could not connect with the oxygen flow meter.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.It was received without the puncture pin protector.A visual exam was performed and damage was found on the internal thread of the adaptor.Several functional tests were performed; however, the oxygen entrainment testing could not be performed as the sample could not be connected correctly to the oxygen supply due to the damage on the adaptor.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 opened to address this issue.

Event Description

The customer alleges that the nebulizer adaptor could not connect with the oxygen flow meter.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• 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: 5623922
• MDR Text Key: 44149510
• Report Number: 3004365956-2016-00202
• 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: 04/12/2016

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 Expiration Date: 06/15/2020
• Device Catalogue Number: 031-33J
• Device Lot Number: 74F1501359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• 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