PREPIERCED MALE ADAPTER PLUG
Received Sep 10, 2019 · Event occurred Jan 1, 2019
Report 9615050-2019-00385 · MDR key 8982466
Device
Generic name
Set, Administration, Intravascular
Manufacturer
Icu Medical Costa Rica Ltd.Catalog number
113010401
Lot number
UNKNOWN
Product problems
- Particulates
- Particulates
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE COMPLAINT OF PARTICULATE MATTER ON THE 113010401 COULD NOT BE CONFIRMED. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE DHR COULD NOT BE REVIEWED DUE TO THE UNKNOWN LOT NUMBER.
Description of Event or Problem
THE EVENT OCCURRED ON AN UNKNOWN DATE THAT INVOLVED A PREPIERCED PORT. THE CUSTOMER REPORTED THAT DURING A CLINICAL DRUG TRIAL FOR AN UNSPECIFIED DRUG, THERE WERE PARTICULATES IN THE INFUSION. THERE IS NO MORE INFORMATION PROVIDED.