MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE 2G; ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT

Model Number 021251-29A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4) distributor (b)(4).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

(b)(4).Leakage at the hub.

Event Description

Irn#: (b)(4).Leakage at the hub.

Manufacturer Narrative

Event took place in france and has been reported through french distributor gamida.Based on risk assessment, interviews and clinical evaluation this file is considered as closed.

• Brand Name: SPROTTE 2G
• Type of Device: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 8099227
• MDR Text Key: 128587919
• Report Number: 9611612-2018-00043
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223024307
• UDI-Public: 14048223024307
• Combination Product (y/n): N
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: 021251-29A
• Device Catalogue Number: 021251-29A
• Device Lot Number: 1264
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other