inforMED
InjuryPPG

TRAY CATH 400ML UM SLIDE TAP 14F SILICONE FOLEY SAFESECURE

Received Mar 19, 2020 · Event occurred Jan 15, 2020

Report 9853356 · MDR key 9853356

Device

Generic name

Kit, Urinary Drainage Collection

Catalog number

UROT1070

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Injury
  • Hematuria
  • Injury
  • Hematuria

Narrative

Description of Event or Problem

THIS FACILITY SAW MULTIPLE PATIENTS WITH INJURY RELATED TO THE 14FR MEDLINE CATHETER. POST INSERTION ATTEMPTS PATIENTS DEVELOPED DIFFERENT SYMPTOMS FROM HEMATURIA, FALSE PASSAGES, URETHRA TRAUMA. THESE PATIENTS REQUIRED CYSTOSCOPIES DUE TO THE TRAUMA/INJURY. SOME REQUIRED A FOLEY POST DISCHARGE FROM THE MEDICAL CENTER. MANUFACTURER RESPONSE FOR TRAY CATH 400ML UM WITH SLIDE TAP 14FR SILICONE FOLEY SAFESECURE CUSTOM, (BRAND NOT PROVIDED) (PER SITE REPORTER). MEDLINE'S RESPONSE WAS THAT THEY HAD NOT SEEN THESE ISSUES AT OTHER FACILITIES. WE ARE RETURNING UNUSED PRODUCT TO MEDLINE.