MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOBLOCK; PERIPHERAL NERVE BLOCK NEEDLE

Model Number	001180-77
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
Event or Problem Description
(b)(4).Obese female patient.Femoral block.Under ultrasound.Resident.The needle has a slight bend next to the hub.The resident pushed down very hard with the probe to be able to see the image.Image was occluded due to fat.The needle curved around the probe and caused a bend in the needle.When the doctor went to retrieve the needle, the needle was dislodged from the hub and stayed inside the patient.There was another procedure to remove the bent needle.The needle bent and broke off from the hub due to extreme ultrasound pressure.
Additional Manufacturer Narrative
Based on risk management and clinical evaluation report this case is considered as closed.Attachment: [complaint report for (b)(4).Pdf].
Event or Problem Description
Irn# (b)(4).Obese female patient.Femoral block.Under ultrasound.Resident.The needle has a slight bend next to the hub.The resident pushed down very hard with the probe to be able to see the image.Image was occluded due to fat.The needle curved around the probe and caused a bend in the needle.When the doctor went to retrieve the needle, the needle was dislodged from the hub and stayed inside the patient.There was another procedure to remove the bent needle.The needle bent and broke off from the hub due to extreme ultrasound pressure.

• Brand Name: SONOBLOCK
• Common Device Name: PERIPHERAL NERVE BLOCK NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7808032
• Report Number: 9611612-2018-00031
• Device Sequence Number: 1313436
• Product Code: BSP
• UDI-Device Identifier: 14048223018733
• UDI-Public: 14048223018733
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2023
• Device Model Number: 001180-77
• Device Catalogue Number: 001180-77
• Device Lot Number: 1245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention