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

Model Number	021163-29A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9611612-2019-00009
• Device Sequence Number: 16192598
• Product Code: BSP
• UDI-Device Identifier: 14048223026950
• UDI-Public: 14048223026950
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention