PED RETURN ELEC
Received Feb 24, 2011
Report 1717344-2011-00140 · MDR key 2004535
Device
Generic name
Pediatric Patient Return Electrode
Manufacturer
Covidien Lp, (valleylab)Catalog number
E751025
Lot number
193113
Product problems
- Detachment Of Device Component
- Device Slipped
- Material Protrusion/Extrusion
Patient
UNK
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). INCIDENT SAMPLES HAVE BEEN RECEIVED AND ARE UNDER EVALUATION. WHEN THE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
THE DISTRIBUTOR REPORTED THAT THEIR CUSTOMER HAD NOTICED A FEW (2-3) DEFECTIVE RETURN ELECTRODES ABOUT A MONTH AGO. THE USER THOUGHT IT WAS AN ISOLATED EVENT. HOWEVER, OVER THE HOLIDAYS THEY NOTICED IT HAPPENING SEVERAL ADDITIONAL TIMES. IT APPEARED THAT THE CORDS WERE COMING LOOSE OR DETACHED. UPON RECEIPT, RETURNED SAMPLES WERE FOUND TO HAVE LOOSE TERMINATION COVERS, WITH EXPOSED FOIL.