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

Catalog Number 41894

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 11/16/2013

Event Type  malfunction  

Event Description

The complaint was reported as: the customer alleges that during the installation oft he nebulizer, the child wanted to take off the device from her face with her right hand.During the removal, by the child, her right index finger was cut by the metal clip.The finger was disinfected and covered with a bandage.The patient condition is reported as fine.

Manufacturer Narrative

Lot number: the lot number for the actual device involved in the incident is unknown, however, the user facility reports that the last lot numbers delivered to their facility are: 02f1301446, 02e1300345, and 02d1300730.A visual, dimensional and functional inspection of the product involved in the complaint could not be conducted since the product involved in the complaint could not be conducted since the product was not returned.The dhr (device history record) of batch number 02f1201446, 02e1300345, and 02d1300730 of material 41894 have been reviewed and no non conformance reports were originated for the lots 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 evaluated the sample involved on 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 on the incident.If the defective sample becomes available, this investigation will be updated with the evaluation results.

• Brand Name: HUDSON NEBULIZER W/PED MASK AND TBG, SMALL VOLUME
• Type of Device: SMALL VOLUME NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; nuevo laredo, tamaulipas ; MX
• Manufacturer (Section G): TELEFLEX; ave. transformacion no.5954; parque industrial finsa; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334964
• MDR Report Key: 3767176
• MDR Text Key: 17264429
• Report Number: 3004365956-2014-00003
• 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: Physician
• Type of Report: Initial
• Report Date: 12/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 41894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2013
• 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
• Patient Age: 14 MO