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

Catalog Number 031-33J

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2017

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 neither the product nor 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 due the lack of product sample to perform a proper investigation, to confirm the alleged defect, and determine the root cause.If the sample becomes available this investigation will be updated with the evaluation results.The personnel of the assembly line were notified on may-09-2017 for awareness.

Event Description

Customer complaint alleges "the user couldn't connect the adapter to the oxygen flow meter.Therefore, a new unit was used instead and the therapy was continued without problem".Alleged malfunction was reported as detected prior to use, during functional testing.No report of patient harm.

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.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 except for the oxygen entrainment test.It was observed that the assembly of the nut adaptor and the upper body component was unstable.The device failed the testing due to the unstable connection.Based on the investigation performed, the reported complaint was confirmed.Although the complaint was confirmed, there is not sufficient evidence to assure that this issue originated during the manufacturing assembly or molding process.The wear on the internal thread of the adaptor is most likely caused by the end user during the connection of the adaptor into the flowmeter.Personnel from the adaptor assembly line at the manufacturing facility were notified of this issue for awareness.

Event Description

Customer complaint alleges "the user couldn't connect the adaptor to the oxygen flow meter.Therefore, a new unit was used instead and the therapy was continued without problem".Alleged malfunction was reported as detected prior to use, during functional testing.No report of patient harm.

• 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: 6568633
• MDR Text Key: 75225870
• Report Number: 3004365956-2017-00194
• 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

• 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: 06/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: 07/19/2017
• Supplement Dates FDA Received: 07/20/2017
• 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