MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE® NRFIT; SPROTTE® NRFIT_NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number	211163-29A
Medical Device Problem Codes	Nonstandard Device (1420); Difficult or Delayed Separation (4044); Device Stenosis (4066)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Irn# (b)(4) complaint took place in (b)(6).Under item h6, codes b, c and d, placeholders have been inserted that have not been verified, as the intial report can only be packed in this form if these are filled in, although no analysis has yet taken place.These b, c and d codes can only be transmitted correctly in the subsequent message as the analysis is still being processed.You will receive the complete report with all test results in the subsequent message.
Event or Problem Description
Irn# (b)(4) incident occurred in (b)(6): spinal needle being used in delivery suite for labouring patient.On withdrawing the introducer it got stuck in the needle so the entire needle and introducer removed and a fresh one used.A new needle used - patient unnecessarily had two spinal needle passes.On examining the faulty needle, there appears to be excess friction between the spinal needle and the introducer implying that the spinal needle has a narrowing.The introduced could be removed (outside of the patient) but then the spinal needle could not be flushed with saline easily.
Event or Problem Description
(b)(4).Incident occurred in great britain: spinal needle being used in delivery suite for labouring patient.On withdrawing the introducer it got stuck in the needle so the entire needle and introducer removed and a fresh one used.A new needle used - patient unnecessarily had two spinal needle passes.On examining the faulty needle, there appears to be excess friction between the spinal needle and the introducer implying that the spinal needle has a narrowing.The introduced could be removed (outside of the patient) but then the spinal needle could not be flushed with saline easily.
Additional Manufacturer Narrative
(b)(4).Complaint took place in great britain.Placeholders were inserted under point h6, codes b, c and d, which were not verified, as the initial report could only be packaged in this form if they were filled in.In this final report, these placeholders from the first report were changed after the root cause analysis.This concerns codes b, c and d.Based on risk assessment and clinical assessment this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.

• Brand Name: SPROTTE® NRFIT
• Common Device Name: SPROTTE® NRFIT_NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 21382653
• Report Number: 9611612-2025-00002
• Device Sequence Number: 8461640
• Product Code: BSP
• UDI-Device Identifier: 04048223116470
• UDI-Public: 04048223116470
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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 Expiration Date: 05/28/2024
• Device Model Number: 211163-29A
• Device Catalogue Number: 211163-29A
• Device Lot Number: 1541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 72 KG