MalfunctionLJS
PowerPICC Provena
Received Jul 28, 2026 · Event occurred Jul 22, 2026
Report 50052453 · MDR key 50052453
Device
Generic name
Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Manufacturer
Bard Access Systems, Inc.Model number
S1274108D3Catalog number
S1274108D3
Lot number
RELQ2186
Product problems
- Delivered as Unsterile Product
- Device Contamination with Chemical or Other Material
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Contaminate (paper/leaf) found inside of dialysis catheter kit upon opening. Discarded kit entirely due to unsterile state.