FDA Adverse Event
Injury
Summary report: N
BD NEEDLE FILTER
MDR report key: 23888631
·
Received December 24, 2025
Report
- Report Number
- 1911916-2025-00812
- Event Type
- Injury
- Date Received
- December 24, 2025
- Date of Event
- November 19, 2025
- Report Date
- January 11, 2026
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- GAA
- UDI-DI
- 00382903052004
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION RESULTS: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
Additional Manufacturer Narrative · 0
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
NO ADDITIONAL INFORMATION.
Description of Event or Problem · 0
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 305200. BATCH#: 2172517. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ADVERSE EVENT - ENDOPHTHALMITIS. PATIENT EXPERIENCED AN ADVERSE EVENT POST INJECTION. LOT 2172517. ADDITIONAL INFORMATION PROVIDED: THERE WAS NO REPORTED ISSUE WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2058060 | BD NEEDLE FILTER | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | GAA | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 2172517 | 00382903052004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |