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

Model Number 4502124-13

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/03/2023

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).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.1.Visual inspection.The complaint sample was not returned.The condition of complaint sample was confirmed from the photo attached in (b)(4).It was observed that the cannula of complaint sample was torn at a position approximately 70 mm from the base of hub.2.Functional test.Result: no abnormality.Bending stiffness test was conducted on the retention sample of cannula pipe in accordance with the testing and measuring method no.: im-2011.The test results met our standards.3.Others.[visual inspection of retention sample].There were no abnormalities such as bent cannula on the appearance of the retention samples (n=5pcs).4.Device history record.Result: no abnormality.Any abnormality was not observed on the manufacturing records of pencan 27gx4 w.Intro.-eu/ap (batch no.22n15h8b05).5.Decision and justification.This complaint is considered as not confirmed.The complaint sample had been used for a procedure, and there were deformations in addition to the broken part.It is presumed that the cannula of the complaint sample was bent and torn during the procedure.

Event Description

As reported by the user facility information by bbm sales organization in france: "needle broken-during use" according to the complainant during a spinal anesthetic, the needle broke when it was removed from the patient.One piece remained and required additional operation to remove.

• 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: 18503960
• MDR Text Key: 332789214
• Report Number: 9610825-2023-00685
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4502124-13
• Device Lot Number: 22N15H8B05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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
• Patient Sex: Female