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

Model Number 041151-30A

Device Problems Fracture (1260); Material Split, Cut or Torn (4008)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

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).Date of event unknown.Breakage of needle.

Manufacturer Narrative

Based on risk management file and clinical evaluation this file is considered as closed.Attachment: [2018 (b)(6)_578_(b)(4)_(initial report #)fu_report.Pdf].

Event Description

Irn# (b)(4).Date of event still unknown.Breakage of needle.

• Brand Name: SPROTTE
• Type of Device: SPINAL ANAESTHESIA CONDUCTION NEEDLE, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7808034
• MDR Text Key: 117960855
• Report Number: 9611612-2018-00035
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223000516
• UDI-Public: 14048223000516
• Combination Product (y/n): N
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

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: Other
• Device Expiration Date: 12/26/2022
• Device Model Number: 041151-30A
• Device Catalogue Number: 041151-30A
• Device Lot Number: 1235
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other