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

Catalog Number 031-33J

Device Problem Connection Problem (2900)

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

Event Date 03/07/2016

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 for review.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed due to the lack of 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)(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 nebulizer adaptor would not connect with the oxygen flow meter.Another adaptor was used.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the internal threads of the adaptor were damaged.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 would not connect with the oxygen flow meter.Another adaptor was used.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE
• 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: 5507115
• MDR Text Key: 40551371
• Report Number: 3004365956-2016-00158
• 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: 03/10/2016

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: 04/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 03/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2016
• 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