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

Catalog Number 031-33J

Device Problem Disconnection (1171)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional, and dimensional 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.A device history record review could not be conducted since the lot number was not provided.A conclusion cannot be established at this time.Customer complaint cannot be confirmed based only on the information received.It is necessary the device sample in order to perform a proper investigation.However, the personnel of the assembly line were notified on for awareness.If the device sample becomes available this report will be updated.

Event Description

Customer complaint alleges "the adaptor was able to connect to the oxygen flow meter without problem; however, after connecting the aquapak to the heater, the connection between the flow meter and screw thread of adaptor were loose and the bottle and adaptor came off." there was no report of patient involvement.There was no report of patient harm or consequence.

Manufacturer Narrative

Qn# (b)(4).One unit of subassembly ph12153 033 nebulizer adaptor phantom holder was received for analysis.This subassembly is part of the finished good (product code 031-33j) nebulizer adaptor 033, sterile, (b)(6), related to this customer complaint.A visual exam was performed and no defects were observed.During the setup of the oxygen entrainment test, it was observed that the assembly of the nut adaptor component and the upper body component was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing with no functional issues.The sample was then assembled with a sterile water concha mini bottle (product code 381-52 reservoir, concha mini 760 ml).It was observed during the setup of the oxygen entrainment test that the assembly of the nut adaptor component and the upper body component disconnected from the nut adaptor.Therefore, it was not possible to perform such testing.The nut adaptor was visually inspected and it was found that the internal locks were worn.Attempts to duplicate the failure mode were performed and there are two ways to duplicate them: the first one is by overtightening the nut adaptor into the flow meter.The second one is by manipulating the assembly connection.(con't) other remarks: 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 wear on the internal thread of nut 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 on sep-4-2017 for awareness.

Event Description

Customer complaint alleges "the adaptor was able to connect to the oxygen flow meter without problem; however, after connecting the aquapak to the heater, the connection between the flow meter and screw thread of adaptor were loose and the bottole and adaptor came off." there was no report of patient involvement.There was no report of patient harm or consequence.

• Brand Name: HUDSON 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6711283
• MDR Text Key: 79960947
• Report Number: 3004365956-2017-00284
• 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: 07/04/2017

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: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 09/05/2017
• Supplement Dates FDA Received: 09/06/2017
• 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