MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; SPINAL NEEDLE

Model Number	021163-29A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(6) 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.
Event or Problem Description
Irn#: (b)(4).Whilst performing a spinal anaesthetic the plastic hub of the needle broke away from the metal needle, leaving the metal needle sticking out of the patients back.No excessive force was used.This is the only report of such an incident in our anaesthetic department.
Event or Problem Description
Irn#:(b)(4).Whilst performing a spinal anaesthetic the plastic hub of the needle broke away from the metal needle, leaving the metal needle sticking out of the patients back.No excessive force was used.This is the only report of such an incident in our anaesthetic department.
Additional Manufacturer Narrative
Based on clinical assessment and risk assessment this file is consideed as closed.

• Brand Name: SPROTTE
• Common Device Name: SPINAL NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 10369803
• Report Number: 9611612-2020-00007
• Device Sequence Number: 2408967
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: 07/15/2024
• Device Model Number: 021163-29A
• Device Catalogue Number: 021163-29A
• Device Lot Number: 1311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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