EXTENDIBLE BRUSH BACKFLUSH INSTRUMENT WITH ACTIVE
Received Feb 22, 2019
Report 1222074-2019-00010 · MDR key 8363449
Device
Generic name
Vitrectomy Fluid/ Gas Handling Handpiece/cannula
Product problems
- Manufacturing, Packaging or Shipping Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
VISUAL INSPECTION HAS SHOWN THAT THE PRODUCTS IN LOT 2000399465 HAVE A SWEEPER TIP INSTEAD OF A BACKFLUSH TIP. ALL OTHER PARTS OF THE INSTRUMENTS IN LOT 2000399465 ARE CORRECT. THE FAULTY TIP WAS CAUSED BY A PRODUCTION ERROR. A FIELD SAFETY CORRECTIVE ACTION WAS INITIATED TO WITHDRAW ALL PRODUCTS OF THE AFFECTED LOT FROM THE MARKET AND REPLACE THEM WITH THE CORRECT ASSEMBLED PRODUCTS. THE TOTAL LOT CONTAINED 60 PRODUCTS ((12 SETS OF 5)). (B)(4). A DESIGN HISTORY REVIEW WAS PERFORMED. NO DEVIATIONS WERE FOUND IN THE PROCESS AND THE USED ARTICLES. TO PREVENT RECURRENCE, AN AWARENESS TRAINING FOR PRODUCTION STAFF INVOLVED IN THE AFFECTED LOT WAS PERFORMED.
Description of Event or Problem
UPON OPENING THE PACKET AND EXTENDING THE TIP, THE PRODUCT WAS FOUND TO HAVE THE INCORRECT TIP ON IT.