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

Model Number 121163-30A

Device Problems Crack (1135); Component Misassembled (4004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(6).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).Initial reporter´s narrative: "patient requiring spinal anaesthetic.Difficult to do, multiple needles used.One needle managed to get into csf unfortunately had a leur lock connection therefore it was not possible to infiltrate any medication.Subsequent needle had to be passed and patient suffered an unneccessary dural puncture.On investigation afterwards it appeared the leur lock needle had been in an nrfit package.".

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

(b)(4).Initial reporter´s narrative: "upon injection of the spinal anaesthetic it was observed that the hub of the needle was cracked & subsequently the anaesthetic was leaking & running down the hub & needle.".

• Brand Name: SPROTTE NRFIT
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 9259874
• MDR Text Key: 220011661
• Report Number: 9611612-2019-00034
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2022
• Device Model Number: 121163-30A
• Device Catalogue Number: 121166-30A
• Device Lot Number: 1213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other