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

Catalog Number 031-33J

Device Problems Disconnection (1171); Connection Problem (2900)

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

Event Date 07/14/2017

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 product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based on the information received at this time.It is necessary to have the device sample to perform a proper investigation and determine the root cause.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges " when 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." the event was reported as prior to patient use.There was no report of harm to the end user.No report of patient involvement or delay in treatment.

Manufacturer Narrative

(b)(4).The sample was received for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no issues were found.It was noticed, however, that during the oxygen entrainment test the assembly of the nut adaptor and the upper body was unstable.Even with that condition, the testing was able to be performed, and the sample passed the test.Based on the investigation performed, the reported complaint was confirmed.There were no issues found with the reported complaint.

Event Description

Customer complaint alleges " when 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." the event was reported as prior to patient use.There was no report of harm to the end user.No report of patient involvement or delay in treatment.

Manufacturer Narrative

(b)(4).Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.

Event Description

Customer complaint alleges " when 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." the event was reported as prior to patient use.There was no report of harm to the end user.No report of patient involvement or delay in treatment.

• 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: 6753621
• MDR Text Key: 81382288
• Report Number: 3004365956-2017-00306
• 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,Followup
• Report Date: 07/21/2017

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: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 07/31/2017
• Supplement Dates Manufacturer Received: 10/02/2017; 10/02/2017
• Supplement Dates FDA Received: 10/03/2017; 10/03/2017
• Was Device Evaluated by Manufacturer?: No
• 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