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

Model Number 021163-29A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

Event took place in the (b)(6) and has been reported through (b)(4) distribution subsidiary (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: patient on elective caesarean section list.Straightforward spinal using the nr fit pajunk sprotte 25g 90mm needle via the supplied 30mm introducer needle.Injected spinal drugs uneventfully.Attempted to remove the introducer and spinal needle as a single unit whereupon the hub of the spinal needle detached from the needle leaving the needle protruding from the patient's back.The needle was subsequently removed manually and was intact.

Event Description

Irn# 620_109-19.Initial reporter´s narrative: patient on elective caesarean section list.Straightforward spinal using the nr fit pajunk sprotte 25g 90mm needle via the supplied 30mm introducer needle.Injected spinal drugs uneventfully.Attempted to remove the introducer and spinal needle as a single unit whereupon the hub of the spinal needle detached from the needle leaving the needle protruding from the patient's back.The needle was subsequently removed manually and was intact.

Manufacturer Narrative

Event took place in the uk and has been reported through british distribution subsidiary pajunk medical ltd.Based on risk assessment and clinical evaluation this file is considered as closed.- attachment: [complaint report for 109-19.Pdf].

• Brand Name: SPROTTE NRFIT
• Type of Device: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 8502928
• MDR Text Key: 141600072
• Report Number: 9611612-2019-00009
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223026950
• UDI-Public: 14048223026950
• Combination Product (y/n): N
• PMA/PMN Number: K160295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

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: 09/11/2020
• Device Model Number: 021163-29A
• Device Catalogue Number: 021167-29A
• Device Lot Number: 1220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention