MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE QUINCKE NRFIT; LUMBAR PUNCTURE NEEDLE

Model Number 1163-3E090

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(6) 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.

Event Description

Irn#: (b)(4).Initial reporter´s narrative: cer: performed a spinal injection and on the removal of the needle from the patient the needle hub came away from the needle its self.This was a straightforward procedure, (b)(6) was able to remove the metal part of the needle as he had one hand on the plastic hub of the needle and one on the metal part of the needle, because of this none of the needle was left in the patient.

Event Description

Irn# (b)(4).Initial reporter´s narrative: cer: performed a spinal injection and on the removal of the needle from the patient the needle hub came away from the needle its self.This was a straightforward procedure, stephen brown was able to remove the metal part of the needle as he had one hand on the plastic hub of the needle and one on the metal part of the needle, because of this none of the needle was left in the patient.

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.

• Brand Name: QUINCKE NRFIT
• Type of Device: LUMBAR PUNCTURE NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 9231208
• MDR Text Key: 219608983
• Report Number: 9611612-2019-00030
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223029357
• UDI-Public: 14048223029357
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: 1163-3E090
• Device Catalogue Number: 1163-3E090
• Device Lot Number: 1294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other