FDA Adverse Event
Malfunction
Summary report: N
INSYTE AUTOGUARD
MDR report key: 25209109
·
Received May 18, 2026
Report
- Report Number
- 9610048-2026-00071
- Event Type
- Malfunction
- Date Received
- May 18, 2026
- Date of Event
- May 4, 2026
- Report Date
- May 19, 2026
- Manufacturer
- BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
- Product Code
- BSP
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION @ COMMON DEVICE NAME.
Additional Manufacturer Narrative · 0
B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
Description of Event or Problem · 0
NO ADDITIONAL INFORMATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE LABEL CONTENT IS INCORRECT. IT WAS REPORTED THAT THE ITEM SKU MAFRA 000310 - RAQUI SPINAL ANESTHESIA NEEDLE 26G X 3 1/2 CX 25UN BD 408380 - EAN 37891463005657 WAS LABELED WITH THE EAN BELONGING TO ANOTHER PRODUCT, SKU MAFRA 008817 - PERI TUOHY ANESTHESIA NEEDLE 18G X 3 1/2 CX 25UN BD 408359 - EAN 37891463005565. THIS IS A DIVERGENCE OF EANS IN THE PHYSICAL IDENTIFICATION, SINCE EACH EAN CORRESPONDS TO A DIFFERENT SKU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 395446 | INSYTE AUTOGUARD | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | BSP | BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. | 5289112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |