MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-33J

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed.It is necessary to have the product sample to perform a proper investigation to confirm the alleged defect, and determine the root cause.If the sample becomes available this report will be updated with the evaluation results.The personnel of the assembly line were notified on mar-19-2018 for awareness.Teleflex will continue to monitor and trend for these complaints.

Event Description

Customer complaint alleges the "adptor was unable to be properly attached to flow meter during product prep.Therefore, it was replaced by a new kit.There is no sample to be returned.".

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7352955
• MDR Text Key: 103006886
• Report Number: 3004365956-2018-00081
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2018

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 03/20/2018
• 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