MalfunctionFEF
BLAKEMORE TUBE
Received Nov 15, 2000
Report 9610520-2000-00098 · MDR key 308688
Device
Generic name
Sengstaken Tube
Manufacturer
Willy Rusch AgModel number
NACatalog number
204860210
Lot number
UNK
Product problems
- Markings, none
Patient
NA
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE TUBE WAS STERILIZED PRIOR TO INITIAL USE. AFTER STERILIZATION IT WAS NOTED THAT THE NUMBERS (DEPTH MEASUREMENTS) HAD COME OFF THE TUBE.