MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEB W/ELONG ADULT MASK,TBG &; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1945

Device Problem Leak/Splash (1354)

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

Event Date 06/28/2019

Event Type  malfunction  

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.

Event Description

Customer reported the device leaked during use.It was reported "there was no medical intervention because it did not characterize an adverse event.The product did not mix and was replaced." no patient harm reported.

Event Description

Customer reported the device leaked during use.It was reported "there was no medical intervention because it did not characterize an adverse event.The product did not mix and was replaced." no patient harm reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the tubing and connector were assembled incorrectly.No other issues were found.The device history record of batch number 74k1801350 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.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.Based on the visual inspection test of the sample received, the complaint is confirmed.A non-conformance has been opened to address this issue.

• Brand Name: HUDSON MICRO MIST NEB W/ELONG ADULT MASK,TBG &
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9250409
• MDR Text Key: 198517043
• Report Number: 3004365956-2019-00316
• 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: 10/10/2019

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: 10/16/2023
• Device Catalogue Number: 1945
• Device Lot Number: 74K1801350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 11/29/2019
• Supplement Dates FDA Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.