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

Model Number	041151-30A
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
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).Date of event unknown.Breakage of needle.
Additional Manufacturer Narrative
Based on risk management file and clinical evaluation this file is considered as closed.Attachment: [2018 (b)(6)_578_(b)(4)_(initial report #)fu_report.Pdf].
Event or Problem Description
Irn# (b)(4).Date of event still unknown.Breakage of needle.

• Brand Name: SPROTTE
• Common Device Name: SPINAL ANAESTHESIA CONDUCTION NEEDLE, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7808034
• Report Number: 9611612-2018-00035
• Device Sequence Number: 11048658
• Product Code: BSP
• UDI-Device Identifier: 14048223000516
• UDI-Public: 14048223000516
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: Other
• Device Expiration Date: 12/26/2022
• Device Model Number: 041151-30A
• Device Catalogue Number: 041151-30A
• Device Lot Number: 1235
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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