MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE 2G; ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT

Model Number	021251-29A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distributor (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 or Problem Description
(b)(4).Leakage at the hub.
Event or Problem Description
Irn#: (b)(4).Leakage at the hub.
Additional Manufacturer Narrative
Event took place in france and has been reported through french distributor gamida.Based on risk assessment, interviews and clinical evaluation this file is considered as closed.

• Brand Name: SPROTTE 2G
• Common Device Name: ANAESTHESIA CONDUCTION NEEDLE, 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: 8099227
• Report Number: 9611612-2018-00043
• Device Sequence Number: 16574561
• Product Code: BSP
• UDI-Device Identifier: 14048223024307
• UDI-Public: 14048223024307
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/19/2018

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: 07/23/2023
• Device Model Number: 021251-29A
• Device Catalogue Number: 021251-29A
• Device Lot Number: 1264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 12/19/2018
• 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