MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV; SMALL VOLUME NEBULIZER

Catalog Number 1734

Device Problem Break (1069)

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

Event Date 07/01/2013

Event Type  malfunction  

Event Description

The complaint was reported as: the customer alleges that the nebulizer is breaking at the male oxygen port.This is occurring when the oxygen tubing is being removed after use.There was no consequence to the patient.

Manufacturer Narrative

The lot number was not provided, therefore, it is not possible to determine in which conditions this material was manufactured.Based on similar complaints a capa ((b)(4)) has been issued in order to identify a root cause and implement corresponding corrective actions.

• Brand Name: HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV
• Type of Device: SMALL VOLUME NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; nuevo laredo, ; MX
• Manufacturer (Section G): TELEFLEX; ave. transformacion 5954; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: margie burton, ra, cs ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3865180
• MDR Text Key: 15121636
• Report Number: 3004365956-2014-00063
• 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,Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1734
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/30/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1