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

Catalog Number	4505913
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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.
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the results with interrupted spinal needle by simulating the course with a pink retractor cannula and a spinal needle withdrawn through the cannula.This has not, despite repeated attempts resulted in a spinal needle of the same make breaking off.However, it cannot be ruled out that the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.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).We received one used spinocan-kan.Kompl.D0.53/120 (25gx4.3/4") without packaging and one spinocan-kan.Kompl.D0.53/120 (25gx4.3/4") in original packaging.The received samples were taken to a visual inspection for damages according to the sap test plan and test method damages.The used cannula is broken off and bend.At the sample in original packaging, we detected no damages and no manufacturing faults.In addition, the outside diameter of the spinocan cannulas were measured according to drawing.Nominal-value: 0.53 +0.01/-0 mm.Actual-value: 0.53 mm - 0.54 mm.The measured value (outside diameters) of the spinocan cannulas are in accordance with the specification.With regard to the broken off and bend sample we assume of a problem during the application process and therefore, we consider the complaint as not confirmed.No abnormalities were found in the manufacturing records of the concerned batches.
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
• 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: 17646474
• Report Number: 9610825-2022-00557
• Device Sequence Number: 5633338
• Product Code: MIA
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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: 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: 08/29/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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