MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; NEEDLE, ANAESTHESIA CONDUCTION, SPINAL, SINGLE SHOT

Model Number	121151-27A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary pajunk medical produkte (b)(4).Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
Event or Problem Description
(b)(4).Tentative translation from initial reporter´s narrative: sectio, unable to gain access to spinal space l3/l4, upon removal of the needle without stylet 40mm from the distal end are missing.
Additional Manufacturer Narrative
Event took place in germany and has been reported through german distribution subsidiary pajunk medical produkte gmbh.Based on risk assessment and clinical evaluation file this case is considered as closed.
Event or Problem Description
Irn# 609_039-18.Tentative translation from initial reporter´s narrative: sectio, unable to gain access to spinal space l3/l4, upon removal of the needle without stylet 40mm from the distal end are missing.

• Brand Name: SPROTTE
• Common Device Name: NEEDLE, ANAESTHESIA CONDUCTION, SPINAL, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 8283976
• Report Number: 9611612-2019-00001
• Device Sequence Number: 14062115
• Product Code: BSP
• UDI-Device Identifier: 14048223001438
• UDI-Public: 14048223001438
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: 121151-27A
• Device Catalogue Number: 121151-27A
• Device Lot Number: 1260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Weight: 109