MalfunctionLIF
RENALIN PR TEST SYSTEM PACKET
Received Apr 18, 2017 · Event occurred Apr 18, 2017
Report MW5069232 · MDR key 6510741
Device
Product problems
- Packaging Problem
Patient
Not reported
- No Information
- No Information
Narrative
Description of Event or Problem
THE LOT NUMBER AND EXPIRATION DATE OF RENALIN PR TEST SYSTEM PACKET ON THE OUTER BAG IS NOT CONSISTENT WITH THE LOT NUMBER AND EXPIRATION OF THE VIAL. EXAMPLE 1: LOT # AND EXPIRATION ON BAG = 789574, 04/2017- LOT # AND EXPIRATION IN VIALS = 796464; 06/2017 (VIAL 1), 793681, 05/2017 (VIAL 2) PRODUCTS WERE NOT OPENED OR USED EXAMPLE 2: LOT # AND EXPIRATION ON BAG = 790182; 04/2017- LOT # AND EXPIRATION IN VIALS = 789573; 05/2017 (VIAL 1), 787110; 04/2017 (VIAL 2). RENALIN PR TEST SYSTEM PACKET PRODUCTS WERE NOT OPENED OR USED.