inforMED
MalfunctionFEZ

BECTON DICKINSON

Received May 24, 2000 · Event occurred Apr 3, 2000

Report 2618282-2000-00004 · MDR key 279865

Device

Generic name

Bonanno Suprapubic Bladder Drainage Catheter

Model number

NA

Catalog number

408289

Lot number

UNK

Product problems

  • Break
  • Leak/Splash
  • Device Issue
  • Device, removal of (non-implant)

Patient

UNKNOWN

  • Urinary Retention
  • Other (for use when an appropriate patient code cannot be identified)
  • Foreign body, removal of
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

PT HAD A VAGINAL HYSTERECTOMY WITH ANTERIOR/POSTERIOR REPAIR AND PLACEMENT OF THE BONANNO SUPRAPUBLIC BLADDER DRAINAGE CATHETER. PT WENT HOME ON 3/27/2000. ON SUNDAY 4/2/00, PT CALLED PHYSICIAN BECAUSE CATHETER WAS LEAKING AT THE INSERTION SITE. PHYSICIAN THOUGHT PERHAPS BLADDER WAS MORE FULL THAN PT THOUGHT. TOLD PT TO UNCLAMP AND DRAIN MORE OFTEN. EVEN AFTER EMPTYING THE BAG THE PT'S BLADDER FELT FULL. ON MONDAY 4/3/00, PT CALLED PHYSICIAN AND TOLD PHYSICIAN THE CATHETER WASN'T WORKING. PHYSICIAN TOLD THE PT TO COME TO THE OFFICE WHERE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER. AS PHYSICIAN ATTEMPTED THE REMOVAL, PHYSICIAN FOUND IT WAS BROKEN NECESSITATING THE PT TO GO TO A UROLOGIST FOR A CYSTOSCOPY TO REMOVE THE PIGTAIL PORTION OF THE CATHETER.