FDA Adverse Event
Malfunction
Summary report: N
SPROTTE
MDR report key: 11989380
·
Received June 14, 2021
Report
- Report Number
- 9611612-2021-00007
- Event Type
- Malfunction
- Date Received
- June 14, 2021
- Date of Event
- May 13, 2021
- Report Date
- October 7, 2021
- Product Code
- BSP
- UDI-DI
- 04048223103876
- PMA / PMN Number
- K911202
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 0
BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT THIS FILE IS CONSIDERED AS CLOSED.
Description of Event or Problem · 0
IRN# (B)(4). "THE INTRODUCERS ARE BENDING AND BREAKING."
Additional Manufacturer Narrative · 1
INFORMATION CURRENTLY QUITE POOR. FOLLOW UP WILL BE SENT IN TO THE AGENCY ONCE MORE INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
IRN#: (B)(4). "THE INTRODUCERS ARE BENDING AND BREAKING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 892274 | SPROTTE | SPINAL NEEDLE, SINGLE USE | BSP | 021151-30A | UNKNOWN | 04048223103876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |