BARD® URINE METER WITH BAG
Received Jul 17, 2026 · Event occurred Jun 30, 2026
Report 1018233-2026-04744 · MDR key 25862300
Device
Generic name
Urine Meter With Bag
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
153204
Lot number
UNK
Product problems
- Difficult to Open or Close
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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
IT WAS REPORTED THAT WHEN ATTEMPTING TO DRAIN THE URINE, THE CAP WOULD NOT OPEN, AND URINE WAS LEAKING FROM THE TIP. CAP OF THE URINE COLLECTION BAG COULD NOT BE REMOVED, AND URINE LEAKAGE OCCURRED.