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

Model Number	021163-29A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2019
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
(b)(4).Needle breakage while a spinal was in process.It bent where the needle left the introdocer.After straightened out the needle broke.Broken end removed successfully.
Additional Manufacturer Narrative
Event took place in the uk and has been reported through british distribution subsidiary pajunk medical ltd.Based on assessment, risk management and clinical considerations this case is considered as closed.
Event or Problem Description
Irn# (b)(4).Needle breakage while a spinal was in process.It bent where the needle left the introdocer.After straightend out the needle broke.Broken end removed successuflly.

• Brand Name: SPROTTE NRFIT
• Common Device Name: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 8710526
• Report Number: 9611612-2019-00015
• Device Sequence Number: 11218016
• Product Code: BSP
• UDI-Device Identifier: 14048223026950
• UDI-Public: 14048223026950
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 01/14/2024
• Device Model Number: 021163-29A
• Device Catalogue Number: 021163-29A
• Device Lot Number: 1285
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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: Required Intervention