MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/TEE; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1884

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "(b)(6) 2019, in (b)(6) hospital , the tube of the nebulization burst suddenly during usage on the patient.Then changing to another one".No patient injury reported.Patient condition listed as "fine".

Event Description

The complaint is reported as: "(b)(6) 2019 , in nanjing integrated traditional chinese and western medicine hospital , the tube of the nebulization burst suddenly during usage on the patient.Then changing to another one." no patient injury reported.Patient condition listed as "fine".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Manufacturer Narrative

(b)(4).The customer returned tubing from catalog number 1884 micro mist nebulizer w/tee, batch 74b1801498 for analysis.During the visual inspection, it was observed that the received sample had ruptured.A dimensional inspection test was performed on the wall thickness of the received tubing and no dimensional issues were found.The affected part of the tubing was cut and a new connector was installed on the tubing in order to perform functional testing to identify any possible issues with the oxygen tubing.During this testing no similar issues were identified.A "burst" as stated on the customer complaint was confirmed based on the investigation of the returned sample; however, the issue cannot be associated with the manufacture of the device.Tubing is designed to allow oxygen flow even when there is an obstruction in the tubing.This is the first time this type of incident is reported.Additional testing was performed on the part removing the affected part and adding a new connector, and no issues that could lead to the reported defect were identified.Although the complaint was confirmed, a root cause could not be identified.

Event Description

The complaint is reported as: (b)(6) 2019 , in nanjing integrated traditional chinese and western medicine hospital , the tube of the nebulization burst suddenly during usage on the patient.Then changing to another one." no patient injury reported.Patient condition listed as "fine".

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8655785
• MDR Text Key: 146640050
• Report Number: 3004365956-2019-00160
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2019

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: 02/15/2023
• Device Catalogue Number: 1884
• Device Lot Number: 74B1801498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 06/03/2019; 07/04/2019
• Supplement Dates FDA Received: 06/09/2019; 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1