B&B MEDICAL TECHNOLOGIES
Received May 15, 2012 · Event occurred Apr 18, 2012
Report 2938401-2012-00001 · MDR key 2629773
Device
Product problems
- Kinked
Patient
27 YR
- Extubate
Narrative
Description of Event or Problem
ON (B)(4) 2012, B&B MEDICAL TECHNOLOGIES WAS CONTACTED BY (B)(6) OF MEDICAL CENTER TO REPORT THAT THERE HAD BEEN AN INCIDENT ON (B)(6) 2012, INVOLVING THE B&B BITE PROOF BITE BLOCK PART NUMBER 11040 LOT# D133437. WHAT OCCURRED ON (B)(6) 2012 WAS THAT THE MEDICAL STAFF WAS NOT ABLE TO INFLATE THE PILOT BALLOON (CUFF) OF A MALLINCKRODT TAPERGUARD EVAC ORAL TRACHEAL TUBE WHILE IN USE ON A PT WITH A B&B BITE PROOF BITE BLOCK. THE ET TUBE WAS REMOVED AND THE PT WAS RE-INTUBATED. AFTER EXAMINING THE INITIAL ET TUBE, IT WAS DISCOVERED THAT THERE WAS A KINK IN THE PILOT TUBING. IT IS UNCLEAR IF KINKED TUBE HAD SIGNIFICANT EFFECT ON PT.
Additional Manufacturer Narrative
PRODUCT TO BE RETURNED AND EVALUATED. EACH BITE PROOF BITE BLOCK IS PACKAGED WITH INSTRUCTIONS FOR USE. INSTRUCTED IN THE INSTRUCTIONS FOR USE IS A CAUTION NOTICE THAT STATES: "SHOULD CUFF FILLING PROBLEM OCCUR, GENTILE PULL THE PILOT BALLOON TUBE TAUT TO REMOVE ANY KINKS."