MalfunctionIWI
RAPIDSTRAND RX
Received Oct 18, 2013 · Event occurred May 16, 2013
Report 2915056-2013-00063 · MDR key 3482053
Device
Product problems
- Manufacturing, Packaging or Shipping Problem
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
REPORT # 2915056-2013-00063 IS A HEALTH PROFESSIONAL REPORT FROM USA THAT INVOLVES A PT-SPECIFIC RAPIDSTRAND RX IMPLANT THAT CONTAINED TWO INCORRECTLY CONFIGURED NEEDLES. THE PRODUCT AUTORADIOGRAPH SHOWED ALL NEEDLES PER TREATMENT PLAN; HOWEVER, THE FACILITY NOTED THAT NEEDLE 25 CONTAINED 3 SEEDS (5 WERE SPECIFIED) AND THAT NEEDLE 26 CONTAINED 5 SEEDS (3 WERE SPECIFIED). QA INVESTIGATION (B)(4) REPORT PENDING.