MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; LUMBAR PUNCTURE NEEDLE

Model Number 121151-30A

Device Problems Failure To Adhere Or Bond (1031); Nonstandard Device (1420); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

Event took place in the (b)(6) and has been reported through (b)(4) distribution subsidiary (b)(4).Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.

Event Description

(b)(4).Initial reporter's narrative: needle shaft detached from hub on insertion in patient.

Manufacturer Narrative

Based on risk management and clinical evaluation this file is considered as closed - (b)(4).

Event Description

(b)(4).Initial reporters narrative: needle shaft detached from hub on insertion in patient.

• Brand Name: SPROTTE
• Type of Device: LUMBAR PUNCTURE NEEDLE
• 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: 7163135
• MDR Text Key: 96519090
• Report Number: 9611612-2018-00003
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223000653
• UDI-Public: 14048223000653
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/29/2017
• Device Model Number: 121151-30A
• Device Catalogue Number: 121151-30A
• Device Lot Number: 1218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2022
• 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): Other