BD NEEDLE PRECISIONGLIDE 21X1IN
Report
- Report Number
- 3003916417-2026-00017
- Event Type
- Malfunction
- Date Received
- January 16, 2026
- Date of Event
- May 5, 2025
- Report Date
- April 29, 2026
- Manufacturer
- BECTON DICKINSON IND. CIRURGICAS LTDA
- Product Code
- FMI
- UDI-DI
- 30000078909794
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD EVA-AI3-SM3 NEEDLE PRECISION GLIDE 21X1IN PACKAGE WAS DAMAGED. VERBATIM: BATCH: 5031737 QUANTITY: (B)(4). REASON: 5 DIRTY IN THE PACKAGING AND INSIDE THE NEEDLE, 2 EXTENSIONS IN THE PROTECTIVE COVER PIERCING THE PACKAGING, 1 DEFORMATION IN THE BEVEL, 1 BROKEN, 1 TEAR IN THE PACKAGING BATCH: 4173465 QUANTITY: (B)(4). REASON: 2 INTERNAL DIRT. BATCH: 4204356 QUANTITY: (B)(4). REASON: 3 FOREIGN BODIES INSIDE THE NEEDLE, 2 DIRT INSIDE THE NEEDLE, 2 BROKEN CANNONS, 1 TEAR IN THE PACKAGING. ADDITIONAL INFORMATION RECEIVED ON 02 JAN 2026 BASED ON THE ANALYSIS OF THE PHOTOS YOU PROVIDED, WE IDENTIFIED THE NEW BATCH NUMBER 4120787 WITH THREE ASSOCIATED PHOTOS. COULD YOU CONFIRM FROM WHICH DISTRIBUTOR THIS BATCH WAS PURCHASED? 4120787 - (B)(6) NF: 1160235 - (B)(4) UNITS DIRTY IT WAS A BATCH WITHOUT INCLUDING WAS THE INCIDENT REPORTED TO ANVISA? IF SO, WHAT IS THE NOTIFICATION NUMBER? NO, ONLY THE COMPANY. COULD YOU CONFIRM THE DATE ON WHICH THE PROBLEM/DEFECT OCCURRED OR WAS IDENTIFIED? 05/05/2025
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 442702 | BD NEEDLE PRECISIONGLIDE 21X1IN | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON IND. CIRURGICAS LTDA | 5031737 | 30000078909794 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |