MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER,LARGE VOLUME,VAR CONCENTRATIO; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1770

Device Problem Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device involved has not been received by the manufacturer for evaluation at the time of this report.However material from the production line was verified and no issues were found that can lead this customer complaint, see attached inspection results.The device history record of batch number 74e1601824 that belong to catalog number 1770 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Customer complaint cannot be confirmed based only on the information provide.To perform a proper investigation and determine the source of the alleged defect reported it is necessary to evaluate the sample involved in this complaint.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the nebulizer is loose in the connection to the nipple, it does not nebulize, the joint is dysfunctional.Reports coronary unit of respiratory therapy."(cont.).Alleged defect reported detected prior to use on a patient during functional testing.No report of patient harm or delay in therapy.

Event Description

Customer complaint alleges "the nebulizer is loose in the connection to the nipple, it does not nebulize, the joint is dysfunctional.Reports coronary unit of respiratory therapy." alleged defect reported detected prior to use on a patient during functional testing.No report of patient harm or delay in therapy.

Manufacturer Narrative

(b)(4).One unit of catalog number 1770 (nebulizer, large volume, var concentration) was received for analysis.During the visual inspection it was observed that there was damage on the internal thread of the nut.No other issues were found.The customer complaint could not be confirmed as the received sample was found with a damage on the internal thread of the nut.With this damage it is not possible to assemble the sample into the flowmeter of the oxygen tank to perform functional testing.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Teleflex will continue to monitor and trend this failure mode.

• Brand Name: HUDSON NEBULIZER,LARGE VOLUME,VAR CONCENTRATIO
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7838373
• MDR Text Key: 119039278
• Report Number: 3004365956-2018-00259
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

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: 1770
• Device Lot Number: 74E1601824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 10/09/2018
• Supplement Dates FDA Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1