BARD URINE METER FOLEY TRAY
Received Dec 31, 2009 · Event occurred Nov 25, 2009
Report 1018233-2009-00160 · MDR key 1569042
Device
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNK
- Laceration(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A DISORIENTED PATIENT'S LEG WAS LACERATED BY THE DRAIN BAG HANGER WHEN ATTEMPTING TO GET OUT OF THE BED WHILE THE BED RAIL WAS IN THE UP POSITION. THE LACERATION OCCURRED TO THE BACK OF THE LEG, PATIENT WAS TAKEN TO THE ER FOR SUTURING. THE FACILITY REPORTED THAT THE BAG WAS IMPROPERLY HUNG ON THE TOP PORTION OF THE BED RAIL WHILE THE PATIENT WAS BEING TRANSPORTED.
Additional Manufacturer Narrative
AS OF TODAY'S DATE, THE SAMPLE HAS BEEN RECEIVED BUT IS CURRENTLY UNDER EVALUATION AT THE MANUFACTURING SITE. THE DHR WAS REVIEWED AND THERE IS NO EVIDENCE OF ANY MANUFACTURING ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATES "POSITION HANGER ON BEDSIDE RAIL NEAR THE FOOT OF THE BED USING SHEETING CLIP TO SECURE DRAINAGE TUBE TO SHEET." A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE SAMPLE INVESTIGATION IS COMPLETE.