MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STANDARD SPROTTE NEEDLE; INTRATHECAL NEEDLE, SINGLE USE

Model Number	321151-31A
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	01/30/2020
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 produkte (b)(4).Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
Event or Problem Description
(b)(4).Summarizing tentative translation of initial reporters narrative: needle came off the hub and had to be removed usig surgical clamp.
Additional Manufacturer Narrative
Event took place in germany and has been reported through german distribution subsidiary pajunk medical produkte gmbh.Based on risk assessment and clinical assessment this file is considered as closed.
Event or Problem Description
(b)(4).Summarizing tentative translation of initial reporters narrative: needle came off the hub and had to be removed usig surgical clamp.

• Brand Name: STANDARD SPROTTE NEEDLE
• Common Device Name: INTRATHECAL NEEDLE, SINGLE USE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 9724718
• Report Number: 9611612-2020-00003
• Device Sequence Number: 2500493
• Product Code: BSP
• UDI-Device Identifier: 14048223002428
• UDI-Public: 14048223002428
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K911260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2022
• Device Model Number: 321151-31A
• Device Catalogue Number: 321151-31A
• Device Lot Number: 1226
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/09/2020
• 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: Required Intervention