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

Model Number	511151-29A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through local distributor.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).Initial reporter´s narrative: recently we received a complaint from one of our customers that a sprotte needle snapped from the hub while being used in surgery.The staff member that encountered this incident has reported this issue to the tga and is very unhappy with the situation.
Event or Problem Description
(b)(4).Initial reporter´s narrative: recently we received a complaint from one of our customers that a sprotte needle snapped from the hub while being used in surgery.The staff member that encountered this incident has reported this issue to the tga and is very unhappy with the situation.
Additional Manufacturer Narrative
Event took place in australia and has been reported through local distributor.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 clinical assessment and risk assessment file is considered as closed.

• Brand Name: SPROTTE
• 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: 9143774
• Report Number: 9611612-2019-00024
• Device Sequence Number: 2208270
• Product Code: BSP
• UDI-Device Identifier: 14048223001605
• UDI-Public: 14048223001605
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K911202
• 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): 12/13/2019

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: 04/22/2024
• Device Model Number: 511151-29A
• Device Catalogue Number: 511151-29A
• Device Lot Number: 1299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• 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