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

Model Number 121251-30A

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 03/24/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(4).From initial reporter´s narrative: when using the product the injection plastic part on the needle suddenly falls of.Parts of the needle was still in the patient's back.The doctor could get the needle without harming the patient.

Event Description

Irn# 560_155-18.From initial reporter´s narrative: when using the product the injection plastic part on the needle suddently falls of.Parts of the needle was still in the patiens back.The doctor could get the needle without harming the patient.

Manufacturer Narrative

Based on risk management assessment and clinical evaluation report this file is considered as closed.- attachment: [2018-09-20_560_155-18_9611612-2018-00024fu_report.Pdf].

• Brand Name: SPROTTE 2.G
• Type of Device: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 07; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7513611
• MDR Text Key: 108497612
• Report Number: 9611612-2018-00024
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223024376
• UDI-Public: 14048223024376
• Combination Product (y/n): N
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: 121251-30A
• Device Catalogue Number: 121251-30A
• Device Lot Number: 1237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other