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

Model Number 4502116N-01

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun internal report number 400637238.A follow-up report will be provided after the examination results are available.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility information by bbm sales organization in the united kingdom: "pencan needle snapped during use" according to the complainant: "we had an incident with a bbraun pencan spinal needle snapping in use, with part retained in patient.Its logged as moderate harm, the patient was referred to a neuro surgeon at another hospital for removal and this occurred the day after incident.Therefore the op for total knee replacement was cancelled as no anaesthetic delivered.Spinal needle broke inside patient during attempted spinal anaesthesia.Spinal attempted initially with 88 millimeter (mm) 25 gage (g) needle, no dural tap.Space too deep.Changed to 103 millimeter (mm) needle for 2nd attempt.Felt gritty resistance around 80 millimeter (mm).Removed needle.On removing the needle, spinal needle found to be snapped at around 50 millimeter (mm) length and could feel the rest of needle under the skin.On spine xray, rest on needle lodged between the spinous processes in the interspinous ligament.".

• 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, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18662615
• MDR Text Key: 334802003
• Report Number: 9610825-2024-00063
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4502116N-01
• Device Lot Number: 21M30A8701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2021
• 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
• Patient Outcome(s): Required Intervention