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

Model Number	021166-29A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vent took place in the (b)(6) and has been reported through (b)(4) distribution subsidiary (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).Initial reporters narrative: whilst performing a spinal the clinician experienced the hub breaking/coming away from the needle leaving the distal part in the patient which was retrieved.
Event or Problem Description
Irn# 610_048-19.Initial reporters narrative: whilst performing a spinal the clinician experienced the hub breaking/coming away from the needle leaving the distal part in the patient which was retrieved.

• Brand Name: SPROTTE NRFIT
• Common Device Name: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT, PRODUCT CODE: BSP
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 8334602
• Report Number: 9611612-2019-00002
• Device Sequence Number: 2418850
• 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,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: 02/12/2023
• Device Model Number: 021166-29A
• Device Catalogue Number: 021163-29A
• Device Lot Number: 1241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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