NV LARGE BORE Y-IRRIGATION SET
Received Jan 25, 2005 · Event occurred Jan 4, 2005
Report 9615050-2005-00014 · MDR key 571155
Device
Generic name
Irrigation Set
Manufacturer
Hospira De Costa Rica Ltd.Model number
NACatalog number
06599
Lot number
201295H
Product problems
- Tip breakage
Patient
67 YR
- Surgical procedure
- Foreign body, removal of
Narrative
Description of Event or Problem
PATIENT WAS UNDERGOING A TRANSURETHRAL RESECTION OF THE PROSTATE. THE CUSTOMER REPORTED THAT 3L GLYCINE BAGS WERE BEING CONSECUTIVELY SPIKED AND REPLACED BY THE CIRCULATING NURSE WHILE GLYCINE WAS DELIVERED VIA GRAVITY. THEIR ROUTINE IS TO CHANGE BAGS, OPEN THE FLOW WIDE OPEN, CLAMP OFF THE EMPTY LINE, AND SPIKE THE NEXT BAG. AFTER CHANGING BAG NUMBER 0 OR 10, THE SURGEON VISUALIZED A FOREIGN FRAGMENT, AND WAS ABLE TO REMOVE IT FROM THE BLADDER WITHOUT SIGNIFICANT DELAY. SUBSEQUENTLY, THE FRAGMENT WAS MATCHED UP WITH A BROKEN SECTION IN THE PIERCING PIN TIP AREA. THERE WAS NO ADVERSE PATIENT EFFECT.
Description of Event or Problem
PATIENT WAS UNDERGOING A TRANSURETHRAL RESECTION OF THE PROSTATE. THE CUSTOMER REPORTED THAT 3L GLYCINE BAGS WERE BEING CONSECUTIVELY SPIKED AND REPLACED BY THE CIRCULATING NURSE WHILE GLYCINE WAS DELIVERED VIA GRAVITY. THEIR ROUTINE IS TO CHANGE BAGS, OPEN THE FLOW WIDE OPEN, CLAMP OFF THE EMPTY LINE, AND SPIKE THE NEXT BAG. AFTER CHANGING BAG NUMBER 9 OR 10, THE SURGEON VISUALIZED A FOREIGN FRAGMENT, AND WAS ABLE TO REMOVE IT FROM THE BLADDER WITHOUT SIGNIFICANT DELAY. SUBSEQUENTLY, THE FRAGMENT WAS MATCHED UP WITH A BROKEN SECTION IN THE PIERCING PIN TIP AREA. THERE WAS NO ADVERSE PATIENT EFFECT.