| Brand Name | Spinocan® |
| Common Device Name | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) |
| Manufacturer (Section D) |
| B. BRAUN MELSUNGEN AG |
| carl-braun-str.1 |
| melsungen, 34212 |
| GM 34212 |
|
| MDR Report Key | 50928062 |
| Report Number | 50928062 |
| Device Sequence Number | 10734713 |
| Product Code |
BSP
|
| UDI-Device Identifier | 04046964833236 |
| UDI-Public | (01)04046964833236(11)260126(17)301231(10)0062053427 |
| Combination Product (Y/N) | N |
| Initial Reporter State | NY |
| Initial Reporter Country | US |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Serviced by Third Party (Y/N) | N |
| Reporter Type |
Voluntary
|
| Initial Reporter Occupation |
Other Health Care Professional
|
| Type of Report
| Initial,Followup |
| Report Date (Section B) |
10/02/2026 |
| Report Date (Section F) |
09/29/2026 |
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
No
|
| Is this a Product Problem Report? |
Yes
|
| Operator of Device |
Health Professional
|
| Device Catalogue Number | 333320 |
| Device Lot Number | 0062053427 |
| Was Device Available for Evaluation? |
Yes
|
| Date Returned to Manufacturer | 09/10/2026 |
| Is the Reporter a Health Professional? |
No
|
| Was the Report Sent to FDA? |
Yes
|
| Distributor Facility Aware Date | 09/03/2026 |
| Device Age | 10 MO |
| Event Location |
Hospital
|
| Date Report to Manufacturer | 09/03/2026 |
| Initial Date Received by Manufacturer | Not provided |
| Supplement Date Received by Manufacturer | Not provided
|
| Initial Report FDA Received Date | 09/29/2026 |
| Supplement Report FDA Received Date | 10/02/2026
|
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N) |
No
|
| Patient Sequence Number | 1 |
| Patient Sex | Unknown |
| Date Report Sent to FDA | 09/29/2026 |
|
|