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

Model Number	4251601-020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Additional 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.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 or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in sweden; "needle broken off." "anesthesiologist is to apply spinal anesthesia to a woman in labor.During the procedure, a pink is used retractor cannula to pierce the skin, the spinal needle is then inserted through the pink cannula (the pink the cannula is used as an introducer).When reversing the spinal needle, it is perceived as being stuck.It comes off but when it comes out of the patient, about 6 cm of the distal part of the spinal needle is missing.After consultation with a spinal surgeon, no immediate action was taken and the patient was delivered.After delivery, a plain x-ray was taken.The needle was superficial.The spine surgeon was able to remove the needle under local anaesthetic.We have tried to replicate the results with interrupted spinal needle by simulating the course with a pink retractor cannula and a spinal needle withdrawn through the cannula.This has not, despite repeated attempts resulted in a spinal needle of the same make breaking off.However, it cannot be ruled out that the faulty active use was the cause of the incident.".

• Brand Name: SPINOCAN®
• Common Device Name: 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 18109
• MDR Report Key: 16075695
• Report Number: 9610825-2020-00557
• Device Sequence Number: 20746937
• Product Code: FRN
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K982805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2022

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 Model Number: 4251601-020
• Device Catalogue Number: 4505913
• Device Lot Number: 19F04A8701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown