FDA Adverse Event Malfunction Summary report: N

HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERVE

MDR report key: 3771149 · Received January 22, 2014

Report

Report Number: 3004365956-2014-00033
Event Type: Malfunction
Date Received: January 22, 2014
Date of Event: December 2, 2013
Report Date: January 6, 2014
Manufacturer: TELEFLEX MEDICAL
Product Code: CAF
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

LOT NUMBER: THE CUSTOMER PROVIDED THREE LOT NUMBERS BUT CANNOT SPECIFICALLY ASSIGN A GIVEN LOT NUMBER TO A GIVEN NEBULIZER. LOT NUMBER 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 ON 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 ON 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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
53508	HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERVE	SMALL VOLUME NEBULIZER	CAF	TELEFLEX MEDICAL		02H1302119, 02F1301975, 02F130

Patients

Seq	Age	Sex	Outcome	Treatment
1