FDA Adverse Event
Malfunction
Summary report: N
DEROYAL
MDR report key: 14915304
·
Received July 5, 2022
Report
- Report Number
- 3014527682-2022-00010
- Event Type
- Malfunction
- Date Received
- July 5, 2022
- Date of Event
- June 22, 2022
- Report Date
- July 5, 2022
- Manufacturer
- DEROYAL
- Product Code
- NNI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
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 · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1450246 | DEROYAL | GUIDEWIRE BOWL | NNI | DEROYAL | HD-395-2000CT | 56580948, 56570871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |