MAUDE Adverse Event Report: TELEFLEX HUDSN DUAL SPRAY MDI ADAPTOR; METERED DOSE INHALER

Catalog Number 1759

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the customer alleges that the mdi adapter is cracking as soon as it is put on a vent.The adapter is switched out for another adapter.No report of patient injury or harm.

Manufacturer Narrative

The device sample was rec'd by the manufacturer, but the investigation is incomplete at the time of this report.

• Brand Name: HUDSN DUAL SPRAY MDI ADAPTOR
• Type of Device: METERED DOSE INHALER
• Manufacturer (Section D): TELEFLEX; research triangle park NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.; research triangle park NC 27709
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; research triangle park, NC 27709 ; 9194334965
• MDR Report Key: 3843259
• MDR Text Key: 4411996
• Report Number: 1044475-2014-00066
• 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: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/03/2014

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: Other
• Device Catalogue Number: 1759
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2014
• Initial Date FDA Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VENT