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 02/13/2018

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 at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.The dhr shows that the device was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.It is necessary to have the physical sample in order to perform a proper and thorough investigation to confirm the alleged defect and determine a root cause.If the sample becomes available, this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges the adaptor was unstable and couldnot be connected to the flow meter properly.Alleged issue reported as prior to patient use.No report of patient involvement.

Event Description

Customer complaint alleges the adaptor was unstable and could not be connected to the flow meter properly.Alleged issue reported as prior to patient use.No report of patient involvement.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was damage on the thread of the adaptor.Functional testing was also performed and the sample passed the tests.During the setup of the oxygen entrainment testing, however, it was observed that the assembly of the nut adaptor and the upper body component was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing but the testing failed.Based on the functional inspection results of the sample received, the complaint is confirmed.Although the condition observed on the sample provided, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The damage found on the thread of the adaptor is most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.Personnel of the assembly line were notified on (b)(6) 2018 for awareness.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7302969
• MDR Text Key: 101572065
• Report Number: 3004365956-2018-00060
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/19/2022
• Device Catalogue Number: 031-33J
• Device Lot Number: 74F1700608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Date Manufacturer Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1