SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY
Received Jul 31, 2017
Report 1018233-2017-04053 · MDR key 6755716
Device
Generic name
Catheter Tray
Manufacturer
Productos Para El Cuidado De La Salud -9611590Catalog number
A897518
Lot number
NGZK5341
Product problems
- Packaging Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: ¿-VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE." 1575, 2199: "NL".
Description of Event or Problem
IT WAS REPORTED THAT THE LUBRICANT SYRINGE DID NOT CONTAIN THE FULL AMOUNT OF LUBRICANT. THE COMPLAINANT ALLEGED THAT THE EXTRA LUBRICANT WAS COLLECTED AND TRAY WAS USED. NO PATIENT INJURY WAS REPORTED
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT THE LUBRICANT SYRINGE DID NOT CONTAIN THE FULL AMOUNT OF LUBRICANT. THE COMPLAINANT ALLEGED THAT THE EXTRA LUBRICANT WAS COLLECTED AND TRAY WAS USED. NO PATIENT INJURY WAS REPORTED.