inforMED
MalfunctionDWZ

DISPOSABLE BIOPSY PACK

Received Apr 19, 1994 · Event occurred Mar 21, 1994

Report MW1001647 · MDR key 12814

Device

Catalog number

398956C-E

Lot number

93087260, 93087261

Product problems

  • Foreign material
  • Misassembled

Patient

*

Narrative

Description of Event or Problem

SUSPECTED CONTAMINATION: ON 3/21/94 WHILE SETTING UP TO DO A ROUTINE RIGHT VENTRICULAR ENDOCARDIAL BIOPSY ON A HEART TRANSPLANT PT, USING A DISPOSABLE BIOPSY PACK, AND AFTER POURING STERILE IV NS SOLUTION INTO THE PLASTIC BOWLS, A NURSE NOTICED A "FILM OF OIL" FLOATING ON THE LIQUID IN THE BOWLS. THE LIQUID WAS FOUND TO HAVE A "FILM" ON TOP PLUS WHAT APPEARED TO BE GLOBULES SUSPENDED NEAR THE SURFACE. A SAMPLE OF THE LIQUID WAS PLACED IN A STERILE CONTAINER AND THE BOWL RETAINED. A NEW METALLIC BOWL WAS ADDED TO THE TRAY IN WHICH STERILE IV NS SOLUTION WAS POURED. THE LIQUID WAS CLEAR AND FREE OF ANY "FILM." ON THURSDAY, 3/24/94, TWO DIFFERENT TRAYS SHOWED A "FILM" ON THE STERILE IV NS IN THE BOWLS. METALLIC BOWLS WERE ONCE AGAIN SUBSTITUTED AND THE LIQUID IN THEM WAS CLEAR AND FREE OF "FILM."