MalfunctionDSA
ANALYER CABLE 12 FT DISPOSABLE
Received Jul 23, 2018 · Event occurred Jul 20, 2018
Report MW5078531 · MDR key 7713996
Device
Generic name
Cable Transducer And Electrode
Manufacturer
Remington Medical, Inc.Model number
S-101-97-12(1)Lot number
1725718
Product problems
- Device Misassembled During Manufacturing /Shipping
Patient
84 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PRODUCT PACKAGE WITH TWO EXTRA PINS IN THE PACKET. PINS WERE IN THE RUBBER COVERING AND DISCOVERED PRIOR TO PT EXPOSURE BUT COULD HAVE DROPPED INTO STERILE FIELD. USED IN ELECTROPHYSIOLOGY LAB.