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

Model Number 121151-27A

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4) 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).Tentative translation from initial reporter´s narrative: sectio, unable to gain access to spinal space l3/l4, upon removal of the needle without stylet 40mm from the distal end are missing.

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 evaluation file this case is considered as closed.

Event Description

Irn# 609_039-18.Tentative translation from initial reporter´s narrative: sectio, unable to gain access to spinal space l3/l4, upon removal of the needle without stylet 40mm from the distal end are missing.

• Brand Name: SPROTTE
• Type of Device: NEEDLE, ANAESTHESIA CONDUCTION, 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: 8283976
• MDR Text Key: 134323010
• Report Number: 9611612-2019-00001
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223001438
• UDI-Public: 14048223001438
• 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: 02/19/2019

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 Expiration Date: 06/25/2023
• Device Model Number: 121151-27A
• Device Catalogue Number: 121151-27A
• Device Lot Number: 1260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 109