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

Catalog Number 1734

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2015

Event Type  malfunction  

Event Description

The complaint is reported as: the oxygen tubing is "popping off" the oxygen source and nebulizer cups during use on the pt.No report of pt injury or harm.

Manufacturer Narrative

(b)(4).A device history record (dhr) review could not be performed as the lot number is unk.The device was not available for eval; therefore, the complaint could not be confirmed.Although there is no inventory of the involved prod available at the mfg facility at this time, current production of catalog number 1706 (up-draft ii opti-neb nebulizer w/adult) that uses the same nebulizer components were tested and no issues were found that could lead to the condition reported by the customer.If the sample becomes available, a f/u report will be submitted with investigation results.

• Brand Name: HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV
• Type of Device: SMALL VOLUME NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4627793
• MDR Text Key: 19346671
• Report Number: 3004365956-2015-00095
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1