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

Model Number	1163-3E090
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: LUMBAR PUNCTURE NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 9231208
• Report Number: 9611612-2019-00030
• Device Sequence Number: 16689534
• Product Code: BSP
• UDI-Device Identifier: 14048223029357
• UDI-Public: 14048223029357
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other