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

Model Number 021163-29A

Device Problem Loss of or Failure to Bond (1068)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2020

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).Whilst performing a spinal anaesthetic the plastic hub of the needle broke away from the metal needle, leaving the metal needle sticking out of the patients back.No excessive force was used.This is the only report of such an incident in our anaesthetic department.

Event Description

Irn#:(b)(4).Whilst performing a spinal anaesthetic the plastic hub of the needle broke away from the metal needle, leaving the metal needle sticking out of the patients back.No excessive force was used.This is the only report of such an incident in our anaesthetic department.

Manufacturer Narrative

Based on clinical assessment and risk assessment this file is consideed as closed.

• Brand Name: SPROTTE
• 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: 10369803
• MDR Text Key: 243717899
• Report Number: 9611612-2020-00007
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223026950
• UDI-Public: 14048223026950
• 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: 09/24/2020

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
• Device Operator: Health Professional
• Device Model Number: 021163-29A
• Device Catalogue Number: 021163-29A
• Device Lot Number: 1311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other