MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE® NRFIT (WITH INTRODUCER); SPINAL NEEDLE, SINGLE-USE

Model Number	AA010287
Medical Device Problem Codes	Nonstandard Device (1420); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in uk.Based on analysis, risk assessment, risk profile and clinical monitoring this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.This product analysis was carried out on the basis of all the information provided and the internal review at pajunk.Based on analysis, risk assessment, risk profile and clinical monitoringthis file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
Irn# (b)(4).Patient attended maternity theatres for an elective lscs under spinal anaesthesia.During attempts at inserting a spinal needle no csf was freely draining from the spinal needle at which point a different operator used a new needle and was able to give a spinal anaesthetic.The case proceeded following this.Upon inspection of the original needle there appeared to be no aperture on the side of the needle to allow passage of csf or injection of intrathecal medication.It was not possible to inject any saline through the needle upon inspection of the needle in the anaesthetic room.
Event or Problem Description
Irn (b)(4) patient attended maternity theatres for an elective lscs under spinal anaesthesia.During attempts at inserting a spinal needle no csf was freely draining from the spinal needle at which point a different operator used a new needle and was able to give a spinal anaesthetic.The case proceeded following this.Upon inspection of the original needle there appeared to be no aperture on the side of the needle to allow passage of csf or injection of intrathecal medication.It was not possible to inject any saline through the needle upon inspection of the needle in the anaesthetic room.
Additional Manufacturer Narrative
Event took place in uk.Based on analysis, risk assessment, risk profile and clinical monitoring this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.This product analysis was carried out on the basis of all the information provided and the internal review at pajunk.Based on analysis, risk assessment, risk profile and clinical monitoring this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.
Additional Manufacturer Narrative
Event took place in uk.Based on analysis, risk assessment, risk profile and clinical monitoring this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.This product analysis was carried out on the basis of all the information provided and the internal review at pajunk.Based on analysis, risk assessment, risk profile and clinical monitoringthis file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
Irn# (b)(4).Patient attended maternity theatres for an elective lscs under spinal anaesthesia.During attempts at inserting a spinal needle no csf was freely draining from the spinal needle at which point a different operator used a new needle and was able to give a spinal anaesthetic.The case proceeded following this.Upon inspection of the original needle there appeared to be no aperture on the side of the needle to allow passage of csf or injection of intrathecal medication.It was not possible to inject any saline through the needle upon inspection of the needle in the anaesthetic room.

• Brand Name: SPROTTE® NRFIT (WITH INTRODUCER)
• Common Device Name: SPINAL NEEDLE, SINGLE-USE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187 ; 0499291586
• MDR Report Key: 19678670
• Report Number: 9611612-2024-00004
• Device Sequence Number: 3239343
• Product Code: BSP
• UDI-Device Identifier: 04048223114803
• UDI-Public: 04048223114803
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: AA010287
• Device Catalogue Number: 021163-29A
• Device Lot Number: 1519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 06/06/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 07/05/2024; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female