PLUG,CATHETER,DRAINAGE PROTECTOR,TUBE
Received May 9, 2024 · Event occurred Apr 2, 2024
Report 1417592-2024-00592 · MDR key 19278248
Device
Generic name
Plug,catheter,drainage Protector,tube
Manufacturer
Medline Industries LpCatalog number
DYND12200
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT "HE CATHETER PLUG IS NOT EFFECTIVE IN PREVENTING URINE OR FLUID FROM LEAKING OUT OF THE CATHETER, CAUSING MITOMYCIN, A CHEMODRUG, TO LEAK OUT OF THE PATIENT'S BLADDER". NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
FLUID LEAKING OUT OF THE CATHETER.