MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICROMIST NEB W/TEE,MTHPC & TBG, SM VOL; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 41892

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.

Event Description

Customer reported "product is leaking from the chamber" during use.A new device was used.No patient injury reported.Patient condition reported as "fine".

Event Description

Customer reported "product is leaking from the chamber" during use.A new device was used.No patient injury reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The customer returned one unit of catalog number 41892 micromist neb w/tee , mouthpiece and tubing, small volume which consists of a jet, jar, cap and tee-connector which were assembled.Visual inspection of the returned components revealed that a foot was missing from the bottom of the jar and that a tubing was not returned.Functional testing was performed and the returned nebulizer unit was used to perform this investigation.A lab inventory tubing was used to connect the nebulizer unit to the air flowmeter.6cc of water was added to the returned nebulizer unit and tubing was connected to an air flowmeter and the pressure was increased to 8 lpm.The functional testing indicated that mist was produced and the chamber did not leak.Therefore, no functional issues were found with the returned nebulizer unit.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.

• Brand Name: HUDSON MICROMIST NEB W/TEE,MTHPC & TBG, SM VOL
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9349411
• MDR Text Key: 189883769
• Report Number: 3004365956-2019-00330
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

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 Catalogue Number: 41892
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.