MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; SPINAL NEEDLE SINGLE USE

Model Number 041251-29A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/20/2022

Event Type  Injury  

Manufacturer Narrative

Based on risk assessment and clinical assessment this file is considered as closed.

Event Description

Irn-# 191-22_761.Event took place in france, tentative translation of initial reporter´s narrative: during a lumbar puncture, the needle broke in the patient's back.On removal, a portion remained in the subcutaneous tissue.Usual lumbar puncture technique (use of introducter and stilet in the needle during removal) overweight paediatric patient 137 kg.Admitted to the neurosurgery unit on 22 june for placement of a ventriculo-atrial shunt and removal of the needle fragment.Infection of the shunt leading to re-hospitalization of the patient with removal of the shunt.

• Brand Name: SPROTTE
• Type of Device: 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: 15101393
• MDR Text Key: 296572628
• Report Number: 9611612-2022-00007
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04048223104316
• UDI-Public: 04048223104316
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/25/2022

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 Operator: Health Professional
• Device Model Number: 041251-29A
• Device Catalogue Number: 041251-29A
• Device Lot Number: 1389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2025
• Initial Date FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention