HUDSON CONCHA RESERVOIR 1500, 1650ML
Received Jul 5, 2013 · Event occurred Jun 17, 2013
Report 1417411-2013-00020 · MDR key 3217186
Device
Generic name
Concha Reservoir Bottle, Sterile Water
Manufacturer
Telefelx MedicalCatalog number
381-50
Lot number
01813A
Product problems
- Material Puncture/Hole
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE EVENT IS REPORTED AS: THE CUSTOMER REPORTS AN INCOMPLETE PUNCTURE OF THE CONCHA RESERVOIR BOTTLE. NO REPORT OF A PATIENT INJURY.
Additional Manufacturer Narrative
A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. THE REVIEW SHOWED NO ISSUES THAT MAY HAVE CONTRIBUTED TO ANY QUALITY ISSUES REPORTED. ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION. ALL IN-PROCESS QA INSPECTIONS WERE ACCEPTABLE. NO SAMPLE RETURNED FROM THE CUSTOMER TO INVESTIGATE. COMPLAINT NOT CONFIRMED. ROOT CAUSE - UNKNOWN. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM CUSTOMERS ON ISSUES RELATED TO PUNCTURE PORT ISSUES FOUND DURING SETUP RELATED TO PUNCTURE PORT ISSUES FOUND DURING SETUP OR ADMINISTERING RESPIRATORY THERAPY WHILE UTILIZING WATER BOTTLE PRODUCTS.