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

Model Number 001151-30A

Device Problems Fracture (1260); Device Handling Problem (3265)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary (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

(b)(4).Tentative summarizing translation from initial reporters narrative: sprotte breaks upon removal through introducer.

Event Description

Irn# (b)(4).Tentative summarizing translation from initial reporters narrative: sprotte breaks upon removal through introducer.

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary pajunk medical produkte (b)(4).Based on risk management and clinical evaluation this file is considered as closed.

• Brand Name: SPROTTE
• Type of Device: ANAESTHESIA CONDUCTING SPINAL NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7284986
• MDR Text Key: 100683586
• Report Number: 9611612-2018-00017
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223000035
• UDI-Public: 14048223000035
• Combination Product (y/n): N
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/12/2022
• Device Model Number: 001151-30A
• Device Catalogue Number: 001151-30A
• Device Lot Number: 50317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention