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 Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2017

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 or a picture of the alleged defect was not provided at the time of this report.A device history record investigation shows that the device was assembled and inspected according to our specifications.It is necessary the physical sample in order to perform a proper and thorough investigation to confirm the alleged defect reported and determine a root cause and corresponding corrective actions.Customer complaint cannot be confirmed based on the information received.Root cause in unknown.No corrective actions can be established at this time.If the device sample becomes available at a later date, this report will be updated accordingly.

Event Description

Customer complaint alleges "the adaptor couldn't attach to the oxygen flow meter straight.(the adaptor was connected aslant to the oxygen flow meter.) therefore, a new unit was used instead." alleged issue reported as prior to patient use, during functional testing.No report of patient harm.

Manufacturer Narrative

(b)(4).The sample was received for evaluation.A visual exam was performed and no defects were observed.The sample was tested on the dual station lift test and the general pull and push test procedures with no functional issues.However, during the setup of the oxygen entrainment test it was observed that the assembly of the nut adaptor and the nebulizer upper body was unstable.Even with that condition, the sample was able to be tested on the oxygen entrainment testing; however, the sample failed the test.Attempts were made to duplicate the loose assembly 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.After the oxygen entrainment testing failed, the component adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection it was found that there was wear on the internal locks.Based on the functional inspection results of the sample received, the complaint is confirmed.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 is most likely caused by the end user during the connection of the adaptor into the flowmeter, which causes an unstable connection.Personnel from adaptor assembly line were notified on (b)(6) 2017 for awareness.

Event Description

Customer complaint alleges "the adaptor couldn't attach to the oxygen flow meter straight.(the adaptor was connected aslant to the oxygen flow meter.) therefore, a new unit was used instead." alleged issue reported as prior to patient use, during functional testing.No report of patient harm.

• 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: 6961263
• MDR Text Key: 90633016
• Report Number: 3004365956-2017-00370
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153010
• 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: 10/10/2017

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: 11/10/2021
• Device Catalogue Number: 031-33J
• Device Lot Number: 74L1601445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• 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