GLIDEPATH
Received Jun 12, 2026 · Event occurred May 23, 2026
Report 3006260740-2026-04045 · MDR key 25481362
Device
Generic name
Dialysis Catheter
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
6393230
Lot number
REKW0622
Product problems
- Tear, Rip or Hole in Device Packaging
- Packaging Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. HOWEVER, A PHOTO WAS PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD 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 BD.
Description of Event or Problem
THE PATIENT WAS PREPPED FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE GLIDEPATH HEMODIALYSIS CATHETER. PRIOR TO THE PROCEDURE, THE OUTER PACKAGING WAS OBSERVED TO BE ALLEGEDLY DAMAGED AND THE STERILITY OF THE DEVICE FOUND TO BE AFFECTED. THERE WAS NO PATIENT CONTACT.