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 12/02/2013

Event Type  malfunction  

Event Description

The event was reported as: the customer alleges that the nebulizer breaks after pt use.The breakage point was at the male oxygen port on the nebulizer.No report of a pt injury or intervention.

Manufacturer Narrative

Lot number - the customer provided three lot numbers but cannot specifically assign a given lot number to a given nebulizer.Lot numbers are: 02h1302119, 02f1301975, 02f1302110.A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation, it is necessary to evaluate the sample involved in the incident.The customer complaint cannot be confirmed based only on the information provided, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident.However current production was verified to identify any issue that can lead to the reported defect and no issues were found.If the defective sample becomes available, this investigation will be updated with the evaluation results.

• 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, clinical speciali ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3771176
• MDR Text Key: 4375620
• Report Number: 3004365956-2014-00038
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1734
• Device Lot Number: 02H1302119
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2014
• 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