MAUDE Adverse Event Report: TELEFLEX HUDSON MADGIC ATOMIZER WITHOUT SYRINGE; NASAL ATOMIZER

Catalog Number MAD700

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that during intubation, the doctor noticed that the tip of the device was missing.The doctor performed a bronchoscopy along with x-rays and saw no missing tip in the patient.No patient injury or consequence.

Manufacturer Narrative

The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.See scanned page.

• Brand Name: HUDSON MADGIC ATOMIZER WITHOUT SYRINGE
• Type of Device: NASAL ATOMIZER
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer (Section G): WOLFE TORY MEDICAL, INC.; 79 west 4500 s ste 18
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4142729
• MDR Text Key: 19802855
• Report Number: 1722554-2014-00004
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MAD700
• Device Lot Number: 140652
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1