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 04/22/2016

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 product was not returned.No photo available.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed due the lack of product 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, regarding other customer complaints due to the same issue, a capa file # (b)(4) was opened to perform a further investigation this issue ((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 will be notified for awareness.

Event Description

The customer alleges that the adaptor was damaged and was unable to connect the adaptor to the heater.Another adaptor was used.

Manufacturer Narrative

(b)(4).Event description has been corrected.The sample was returned for evaluation.A visual exam was performed and it was observed that the internal threads of the adaptor were damaged.Functional testing was performed; however, oxygen entrainment testing could not be performed because the adaptor could not be connected correctly to the oxygen supply due to the damage on the internal thread.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 user was not able to connect the adapter to the oxygen flow meter.Another adaptor was used.

• 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: 5643482
• MDR Text Key: 44891833
• Report Number: 3004365956-2016-00209
• 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: 04/26/2016

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: 031-33J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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