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

Model Number 021163-29A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

(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).Initial reporter´s narrative: upon removal of the sprotte 25g spinal needle the hub became detached from the needle.Resulting in forceps needed to be used to remove the spinal needle from the patient's back.

Manufacturer Narrative

Event took place in the (b)(6) and has been reported through (b)(4) distribution subsidiary (b)(4).Based on risk assessment and clinical evaluation file is considered as closed.

Event Description

Irn# (b)(4).Initial reporter´s narrative: upon removal of the sprotte 25g spinal needle the hub became detached from the needle.Resulting in forceps needed to be used to remove the spinal needle from the patients back.

• Brand Name: SPROTTE NRFIT
• Type of Device: ANAESTHESIA CONDUCTING SPINAL NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7284984
• MDR Text Key: 100683428
• Report Number: 9611612-2018-00016
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: K160295
• 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: 03/09/2018

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: Physician
• Device Expiration Date: 11/20/2022
• Device Model Number: 021163-29A
• Device Catalogue Number: 021163-29A
• Device Lot Number: 47217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 02/12/2018
• Supplement Dates FDA Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention