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	06/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Irn# (b)(4).Device was being used to adminster spinal anaesthesia for a emergency lower segment caesarean section.Anaesthetist was unable to inject through the device after feeling loss of resistance /give.Device was removed.It was noted that the spinal needle did not have any holes at the tip which should have helped to inject the medication.
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.
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.
Event or Problem Description
Irn# (b)(4).Device was being used to administer spinal anaesthesia for a emergency lower segment caesarean section.Anaesthetist was unable to inject through the device after feeling loss of resistance /give.Device was removed.It was noted that the spinal needle did not have any holes at the tip which should have helped to inject the medication.
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.Correction: imdrf codes: b15 to b01; c19 to c16 and d14 to d03.The error/cause analysis was also supplemented by the test result of the subsequently delivered failure samples (b)(6).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.
Event or Problem Description
Irn# (b)(4) device was being used to adminster spinal anaesthesia for a emergency lower segment caesarean section.Anaesthetist was unable to inject through the device after feeling loss of resistance /give.Device was removed.It was noted that the spinal needle did not have any holes at the tip which should have helped to inject the medication.
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.Correction: imdrf codes: b15 to b01; c19 to c16 and d19 to d03.The error/cause analysis was also supplemented by the test result of the subsequently delivered failure samples (2024-08-26).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).Device was being used to administer spinal anaesthesia for an emergency lower segment caesarean section.Anaesthetist was unable to inject through the device after feeling loss of resistance /give.Device was removed.It was noted that the spinal needle did not have any holes at the tip which should have helped to inject the medication.

• 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: 19700818
• Report Number: 9611612-2024-00007
• Device Sequence Number: 7785401
• 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,Followup
• Report Date (Section B): 09/09/2024

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
• Device Model Number: AA010287
• Device Catalogue Number: 021163-29A
• Device Lot Number: 1507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 06/19/2024; 06/19/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/10/2024; 08/28/2024; 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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: Unknown