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

Model Number 121163-30A

Device Problems Loss of or Failure to Bond (1068); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 09/24/2019

Event Type  malfunction  

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 Description

Irn# (b)(4).Performed spinal as usual although ligamnet was tough, the spinal worked fine.On removal of the spinal needle the hub was detached from the metal part.Surgical needle holders were required to remove the metal part of the needle from the patients back.

Manufacturer Narrative

Event took place in the uk and has been reported through british 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.Based on risk assessment and clinical assessment file is considered as closed.

Event Description

Irn# (b)(4).Initial reporter´s narrative: performed spinal as usual although ligamnet was tough, the spinal worked fine.On removal of the spinal needle the hub was detached from the metal part.Surgical needle holders were required to remove the metal part of the needle from the patients back.

• Brand Name: SPROTTE NRFIT
• Type of Device: 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: 9143775
• MDR Text Key: 195107881
• Report Number: 9611612-2019-00027
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223026905
• UDI-Public: 14048223026905
• Combination Product (y/n): N
• PMA/PMN Number: K160295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: 121163-30A
• Device Catalogue Number: 121163-30A
• Device Lot Number: 1294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other