FDA Adverse Event
Injury
Summary report: N
STERICAN 0.50X40 25GX1 1/2 DENTAL - US
MDR report key: 3952806
·
Received July 18, 2014
Report
- Report Number
- 2523676-2014-00281
- Event Type
- Injury
- Date Received
- July 18, 2014
- Date of Event
- July 1, 2014
- Report Date
- July 10, 2014
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FMI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
AS REPORTED BY THE USER FACILITY: NEEDLE BROKE INTO THE PT'S SUBCUTANEOUS TISSUE. PT WITH LUMBAR FACET ARTHROPATHY WAS UNDERGOING LEFT AND RIGHT SIDED L4,L5 AND SACRAL MEDIAL BRANCH BLOCKS. THE LEFT SIDE BLOCK WAS COMPLETED. ATTENTION WAS THEN TURNED TO THE RIGHT L5 LOCATION. DURING INFILTRATION WITH A 25 GAUGE X 1.5 INCH NEEDLE THE INFILTRATION NEEDLE BROKE INTO THE SUBCUTANEOUS TISSUE OF THE PT. ATTEMPTS TO REMOVE THE NEEDLE MAKE TWO 1CM INCISION UNDER THE SKIN UNDER LIVE FLUOROSCOPY WERE UNSUCCESSFUL. THE INCISIONS WERE SUTURED. THE PT WAS INFORMED AND INSTRUCTED TO RETURN FOR SURGICAL REMOVAL OF THE TRAINED NEEDLE. THE NEEDLE WAS REMOVED WITH A LAPAROSCOPIC NEEDLE DRIVER SUCCESSFULLY." NO SAMPLES. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423274 | STERICAN 0.50X40 25GX1 1/2 DENTAL - US | INJECTION NEEDLES | FMI | B. BRAUN MELSUNGEN AG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |