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

Model Number 321151-31A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2020

Event Type  malfunction  

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 Description

(b)(4).Summarizing tentative translation of initial reporters narrative: needle came off the hub and had to be removed usig surgical clamp.

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 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
• Type of Device: 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
• MDR Text Key: 221865502
• Report Number: 9611612-2020-00003
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223002428
• UDI-Public: 14048223002428
• Combination Product (y/n): N
• PMA/PMN Number: K911260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention