MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE NRFIT; NEEDLE, ANAESTHESIA CONDUCTION, SINGLE SHOT

Model Number	121163-30A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in the (b)(6) and has been reported through (b)(4).Currently the data is poor and the device has not been sent back/analysed.As soon as further data will be available a follow up report will be sent in to the agency.
Event or Problem Description
Irn# (b)(4).Performed spinal as usual although ligamnet was tough, the spinal worked fine.On removal of the spinal needle the hub was detached from the metal part.Surgical needle holders were required to remove the metal part of the needle from the patients back.
Additional Manufacturer Narrative
Event took place in the uk and has been reported through british distribution subsidiary pajunk medical ltd.Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.Based on risk assessment and clinical assessment file is considered as closed.
Event or Problem Description
Irn# (b)(4).Initial reporter´s narrative: performed spinal as usual although ligamnet was tough, the spinal worked fine.On removal of the spinal needle the hub was detached from the metal part.Surgical needle holders were required to remove the metal part of the needle from the patients back.

• Brand Name: SPROTTE NRFIT
• Common Device Name: NEEDLE, ANAESTHESIA CONDUCTION, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 9143775
• Report Number: 9611612-2019-00027
• Device Sequence Number: 13557928
• Product Code: BSP
• UDI-Device Identifier: 14048223026905
• UDI-Public: 14048223026905
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 03/18/2024
• Device Model Number: 121163-30A
• Device Catalogue Number: 121163-30A
• Device Lot Number: 1294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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