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

Model Number 511151-29A

Device Problems Loss of or Failure to Bond (1068); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2019

Event Type  malfunction  

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 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 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.

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
• 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: 9143774
• MDR Text Key: 219774370
• Report Number: 9611612-2019-00024
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223001605
• UDI-Public: 14048223001605
• Combination Product (y/n): N
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

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 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
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other