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

Model Number	041251-29A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on risk assessment and clinical assessment this file is considered as closed.
Event or Problem 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
• 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
• MDR Report Key: 15101393
• Report Number: 9611612-2022-00007
• Device Sequence Number: 17191065
• Product Code: BSP
• UDI-Device Identifier: 04048223104316
• UDI-Public: 04048223104316
• 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: Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• 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