MalfunctionFEF
BARD BUTTON DEVICE DECOMP
Received May 18, 2000 · Event occurred Mar 27, 2000
Report 1223688-2000-00020 · MDR key 279470
Device
Generic name
Decompression Tube
Manufacturer
Bipd Div Cr BardModel number
61 00351Catalog number
61 000351
Lot number
UNK
Product problems
- Partial Blockage
- Restricted Flow rate
- Replace
- Other (for use when an appropriate device code cannot be identified)
Patient
9 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PARENT STATES TOOK TUBE OUT OF PACKAGE FOR FIRST TIME USE. PLACED DECOMPRESSION TUBE INTO BARD BUTTON, BEGAN TO DRAW UP ON SYRINGE AND NOTED NO RESIDUAL. REMOVED TUBE FROM BUTTON AND NOTED THE HOLE ON PROXIMAL END OF ADAPTER WAS TOO SMALL. USED ANOTHER DECOMPRESSION TUBE.
Remedial action
- Recall