MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER W/PED MASK & TBG, SMALL VOLUME; SMALL VOLUME NEBULIZER

Catalog Number 41893

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2013

Event Type  malfunction  

Event Description

The complaint was reported as: the customer alleges that the device stopped producing a mist shortly after the treatment was started.No clinical consequences to the patient.The device (mask) was changed out.The patient condition is reported as fine.

Manufacturer Narrative

Device available for evaluation? the availability of the device sample was not reported.A visual, dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The dhr (device history record) of batch number 02k1201672 of material (b)(4) was reviewed and no non conformance reports were originated for the lot in question that can be associated to the complaint reported.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 info provided, in order to perform a proper investigation, it is necessary to evaluate the sample involved in the incident.If the defective sample becomes available, this investigation will be updated with the evaluation results.

• Brand Name: HUDSON NEBULIZER W/PED MASK & TBG, SMALL VOLUME
• Type of Device: SMALL VOLUME NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; nuevo laredo, tamaulipas ; MX
• Manufacturer (Section G): TELEFLEX; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton, ra clinical splst ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3647357
• MDR Text Key: 16057771
• Report Number: 3004365956-2014-00002
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/12/2013

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: 41893
• Device Lot Number: 02K1201672
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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