600 ML NAVARRE® UNIVERSAL GRAVITY DRAINAGE BAG
Received Apr 17, 2020
Report 3006260740-2020-01430 · MDR key 9975064
Device
Generic name
Drainage Catheter Acessory
Manufacturer
Bard Access SystemsModel number
NDB600Catalog number
NDB600
Lot number
UNKNOWN
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
FOR THE REPORTED EVENT, LOT NUMBER WAS NOT PROVIDED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICE WAS LABELED FOR SINGLE USE.
Description of Event or Problem
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL NDB600 DRAINAGE CATHETER ACCESSORY ALLEGEDLY EXPERIENCED FLUID LEAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.