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

Catalog Number 031-33J

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2017

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 was not returned.A picture of the defect was not provided.A device history record review shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of device sample to perform a proper investigation 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 for awareness.

Event Description

Customer complaint alleges "after connecting the nebulizer adaptor to the oxygen flow meter, the connection part assembly to the flowmeter came off the nebulizer adapter, so the aquapak bottle and adaptor fell from the flowmeter." alleged event occurred prior to patient use, during inspection/functional testing.No report of patient involvement.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was found there were damages on the internal locks of the adaptor.Because of the damage found on the internal locks of the adaptor, the sample is not acceptable according to current specifications.Although the sample was not acceptable, the dual station lift test and the general pull and push test was performed with no functional issues.During the setup of the oxygen entrainment test, it was observed that the assembly of the nut adaptor and the upper body was unstable as the upper body was disconnected from the nut adaptor.Therefore, it was not possible to perform such testing.Based on the investigation performed, the reported complaint was confirmed.Although the condition reported is observed on the sample provided, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process (damaged internal locks).The root cause for the condition reported could not be identified.However, the personnel from the adaptor assembly line will be notified for awareness.*a conclusion code could not be chosen as the complaint was confirmed; however, a root cause could not be established.

Event Description

Customer complaint alleges "after connecting the nebulizer adaptor to the oxygen flow meter, the connection part assembly to the flowmeter came off the nebulizer adapter, so the aquapak bottle and adaptor fell from the flowmeter." alleged event occurred prior to patient use, during inspection/functional testing.No report of patient involvement.

• 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: 6417374
• MDR Text Key: 70360692
• Report Number: 3004365956-2017-00107
• 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: 03/13/2017

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 Expiration Date: 08/19/2021
• Device Catalogue Number: 031-33J
• Device Lot Number: 74H1602412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• 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 FLOWMETER