FDA Adverse Event
Injury
Summary report: N
SUPERDIMENSION ASPIRATING NEEDLE
MDR report key: 19011049
·
Received April 1, 2024
Report
- Report Number
- 1220592-2024-00001
- Event Type
- Injury
- Date Received
- April 1, 2024
- Date of Event
- March 8, 2024
- Report Date
- April 1, 2024
- Manufacturer
- HOBBS MEDICAL, INC.
- Product Code
- GAA
- UDI-DI
- 10884521843196
- PMA / PMN Number
- K860582
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO NEEDLES HAD DIFFICULTY DEPLOYING, AND DID NOT GET ANY TISSUE SAMPLE. IT WAS NOTED THAT THE NODULE CHARACTERISTICS (HARD TISSUE) OR WERE NOT IN THE CORRECT SPOT FOR DEPLOYMENT. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. HOWEVER, AFTER THE PROCEDURE, THE PATIENT HAD PNEUMOTHORAX. REPORT 1 OF 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1567213 | SUPERDIMENSION ASPIRATING NEEDLE | ASPIRATING NEEDLE | GAA | HOBBS MEDICAL, INC. | SDAN1000 | SD04-23-111 | 10884521843196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| O |