FDA Adverse Event
Malfunction
Summary report: N
ALARA NEURO ACCESS NEEDLE
MDR report key: 22019294
·
Received May 14, 2025
Report
- Report Number
- 3012495575-2025-00004
- Event Type
- Malfunction
- Date Received
- May 14, 2025
- Date of Event
- April 8, 2025
- Report Date
- April 23, 2025
- Manufacturer
- SURGENTEC, LLC
- Product Code
- PDQ
- UDI-DI
- 00858406007303
- PMA / PMN Number
- K190163
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
REP SENT IN A USAGE SHEET THAT SHOWED EXPIRED PRODUCT WAS USED IN THE CASE. THE DATE OF THE CASE WAS APRIL 8TH, 2025 AND THE PRODUCT EXPIRED ON MARCH 31ST, 2025. NO PATIENT HARM WAS REPORTED AND THE PATIENT WAS NOT UNDER ANESTHESIA LONGER THAN ORIGINALLY ANTICIPATED. WE DID NOTIFY THE REP ON 3/11/25 THAT THE PRODUCT WAS ABOUT TO EXPIRE AND REQUESTED FOR IT TO BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1600710 | ALARA NEURO ACCESS NEEDLE | NERVE STIMULATOR / LOCATOR | PDQ | SURGENTEC, LLC | 22SUR0282 | 00858406007303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |