MalfunctionNNI
DEROYAL
Received Jul 5, 2022 · Event occurred Jun 22, 2022
Report 3014527682-2022-00010 · MDR key 14915304
Device
Generic name
Guidewire Bowl
Manufacturer
DeroyalModel number
HD-395-2000CTCatalog number
HD-395-2000CT
Lot number
56580948, 56570871
Product problems
- Contamination
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE GUIDEWIRE BOWL WAS USED AS A COMPONENT INSIDE OF ROI CPS, LLC CUSTOM KIT 880393003, LOT 92614 - CARDIAC CATH KIT. THE INITIAL REPORTER DID NOT RETAIN THE SAMPLE OR RETURN IT TO ROI CPS, LLC FOR EVALUATION OR FOR RETURN TO THE MANUFACTURER DEROYAL.
Description of Event or Problem
DEBRIS WAS FOUND IN GUIDEWIRE BOWL UPON OPENING THE CARDIAC CATHETER PACK. THERE WAS NO PATIENT CONTACT OR DELAY IN THE CASE. A NEW PACK WAS OPENED FOR USE.