BARD 350ML URINE METER DRAIN BAG
Received Aug 23, 2011 · Event occurred Jul 21, 2011
Report 1018233-2011-00198 · MDR key 2230796
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
UNK
- Injury
- Surgical procedure, additional
Narrative
Additional Manufacturer Narrative
THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, PHOTOGRAPHIC IMAGES WERE SENT IN LIEU OF THE ACTUAL DEVICE. VISUAL INSPECTION OF THE DEVICE IN THE PHOTOS DID NOT REVEAL ANY ANOMALIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DIMENSIONAL VALUES COULD NOT BE ASSESSED W/O THE ACTUAL SAMPLE. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE GUIDELINES FOR DRAINAGE FOR THE BARD URINARY SYSTEM STATES, "URINARY DRAINAGE BAG SHOULD BE PLACED NEAR THE FOOT OF THE BED, AND BELOW THE LEVEL OF THE PATIENT'S HIP." BASED UPON THE REPORTED EVENT AND VISUAL INSPECTION OF THE PHOTOS, THE DEVICE WAS HUNG ON THE BED'S MOVABLE SIDERAIL AND THE SIDERAIL WAS UP DURING THE INCIDENT. THERE WAS NO PROBLEM WITH THE DEVICE. THE EVENT OCCURRED AS A RESULT OF THE PATIENT MOVING HER LEG OVER THE BEDRAIL WHERE THE BAG WAS HANGING. THE DRAINAGE BAG WAS NOT HUNG NEAR THE FOOT OF THE BED AND BELOW THE LEVEL OF THE PATIENT'S HIP ACCORDING TO THE GUIDELINES FOR DRAINAGE. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT WHEN THE PATIENT MOVED HER LEG OVER THE BED RAIL TO SIT UP, HER LEG GOT CAUGHT ON THE BAG HOOK CAUSING A 5CM TRIANGULAR SKIN TEAR ON THE CALF PORTION OF HER LEG. THE PATIENT REQUIRED SUTURES TO CLOSE THE SKIN TEAR.