BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER
Received Jul 26, 2017
Report 1018233-2017-03949 · MDR key 6745607
Device
Generic name
Urethral Tray
Manufacturer
Productos Para El Cuidado De La Salud -9611590Model number
772417Catalog number
772417
Lot number
UNK
Product problems
- Component Missing
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "- CONTENTS: VINYL CATHETER, 14 FR. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. LUBRICATE CATHETER. PROCEED WITH CATHETERIZATION IN USUAL MANNER. IF SPECIMEN IS REQUIRED, FILL STERILE CONTAINER FROM CATHETER." (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE CATHETER KIT DID NOT CONTAIN A CATHETER.
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.
Description of Event or Problem
IT WAS REPORTED THAT THE CATHETER KIT DID NOT CONTAIN A CATHETER.