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 04/17/2017

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 shows that the device was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of the device sample to perform a proper investigation and determine the root cause.However, the personnel of the assembly line were notified for awareness.If the sample becomes available at a later date, this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges that the connection between the adaptor and the oxygen flow meter was unstable, due to the adaptor didn't fit the flow meter properly.Alleged defect reported as detected during inspection/functional testing prior to patient use.No report of patient involvement.No report of delay in treatment.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the internal thread of the adaptor was worn and it did not spin freely.No other issues were found.The wear found on the internal thread of the adaptor is not acceptable according to the current specifications.Even with that condition, the sample was functionally tested.The device passed all tests with no issues.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

Customer complaint alleges that the connection between the adaptor and the oxygen flow meter was unstable, due to the adaptor didn't fit the flow meter properly.Alleged defect reported as detected during inspection/functional testing prior to patient use.No report of patient involvement.No report of delay in treatment.

• 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: 6570447
• MDR Text Key: 75324286
• Report Number: 3004365956-2017-00193
• 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
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/23/2021
• Device Catalogue Number: 031-33J
• Device Lot Number: 74H1602627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2016
• 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
• Treatment: OXYGEN FLOW METER