MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG SPINOCAN®; SPINAL NEEDLE

Model Number 4251601-020

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/20/2022

Event Type  Injury  

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in germany: "cannula is broken off." "the cannula broke in the spinal canal during the birth preparation "sectio".And had to be surgically removed by a neurosurgeon, after the birth of the child.".

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).The complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.

• Brand Name: SPINOCAN®
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14960137
• MDR Text Key: 295523201
• Report Number: 9610825-2022-00262
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4251601-020
• Device Catalogue Number: 4505905-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1