MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE®; SPROTTE®_SPINAL NEEDLE_SINGLE -USE

Model Number	511151-29A
Medical Device Problem Codes	Nonstandard Device (1420); No Flow (2991)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in france.Due to a missing fda code, the imdrf-e21 code procedural complications, an fda code 2388 "inadequate pain relief" adapted to the patient situation was selected.It would be advantageous if the fda were to initiate the assignment of the corresponding fda code for imdrf - e, e21 procedural complications.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).Incident occurred in france: original text: rachianesthésie pour cure d'hémorroïdes chez un patient obèse.Utilisation d'une aiguille, ponction facile mais pas de reflux de liquide céphalo rachidien.3 essais supplémentaires infructueux, le dernier essai avec des douleurs irradiant la fesse droite probablement liées au frottement avec une racine.Arrêt des essais de ponction, test de l'aiguille avec du sérum.Constat d'impossibilité d'injection (et donc de reflux du liquide céphalo-rachidien car semble bouché.Conséquences: 4 ponctions dans la dure mère, risques de céphalées post durales, hématomes péri-médullaire, lésions neurologiques et porte d'entrée infectieuse.Actions entreprises : arrêt complet des essais pour une rachianesthésie.Une anesthésie générale a été faite.Suivi post opératoire : ras translation: spinal anesthesia for hemorrhoid treatment in an obese patient.Use of a needle, easy puncture but no reflux of cerebrospinal fluid.3 further unsuccessful attempts, the last one with pain radiating to the right buttock, probably due to friction with a root.Puncture attempts stopped; needle tested with serum.No injection possible (and therefore no cerebrospinal fluid reflux, as it seems blocked).Consequences: 4 punctures into the dura mater, risk of post-dural headaches, peri-medullary haematomas, neurological lesions and infectious portal of entry.Action taken: complete cessation of spinal anaesthesia trials.General anaesthesia was used.Postoperative follow-up: all clear.

• Brand Name: SPROTTE®
• Common Device Name: SPROTTE®_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
• MDR Report Key: 20629281
• Report Number: 9611612-2024-00026
• Device Sequence Number: 12627125
• Product Code: BSP
• UDI-Device Identifier: 04048223116753
• UDI-Public: 04048223116753
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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: 511151-29A
• Device Catalogue Number: 511151-29A
• Device Lot Number: 1527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown