MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC PORTEX FLO-MIST; NEBULIZER

Catalog Number 11-4100

Device Problems Defective Device (2588); Connection Problem (2900)

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

Event Date 03/14/2016

Event Type  malfunction  

Event Description

The flow meter attachment on top of the portex flo mist, ref# 11-4100, lot# 2803927, was defective, unable to attach to the flowmeter because it is upside down.Went through stock and found another defective flo mist from same ref and lot number.

• Brand Name: PORTEX FLO-MIST
• Type of Device: NEBULIZER
• Manufacturer (Section D): SMITHS MEDICAL ASD INC; 160 weymouth st.; rockland MA 02370
• MDR Report Key: 5566827
• MDR Text Key: 42305321
• Report Number: 5566827
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2014
• Device Catalogue Number: 11-4100
• Device Lot Number: 2803927
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO