FDA Adverse Event
Malfunction
Summary report: N
ENCOR ENSPIRE SYSTM 115V
MDR report key: 11371936
·
Received February 24, 2021
Report
- Report Number
- 2020394-2021-00325
- Event Type
- Malfunction
- Date Received
- February 24, 2021
- Date of Event
- January 28, 2021
- Report Date
- February 17, 2021
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- KNW
- UDI-DI
- 00801741086113
- PMA / PMN Number
- K111100
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 12/2099)
Description of Event or Problem · 1
IT WAS REPORTED THAT POST BIOPSY PROCEDURE, THE CANISTER WAS ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271344 | ENCOR ENSPIRE SYSTM 115V | BIOPSY INSTRUMENT | KNW | BARD PERIPHERAL VASCULAR, INC. | E4115 | 00801741086113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |