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

Catalog Number 031-33J

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved was reported as disposed of by the user facility.The device history record of batch number 74m1701663 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.No root cause can be determined.No corrective actions can be assigned.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges the connection part of the assembly to the flowmeter came off.A new unit was obtained for use.It was reported there was no patient involvement.

• Brand Name: HUDSIN 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: 8170211
• MDR Text Key: 130634674
• Report Number: 3004365956-2018-00364
• 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: 11/29/2018

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 Expiration Date: 12/14/2022
• Device Catalogue Number: 031-33J
• Device Lot Number: 74M1701663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2017
• 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