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

Model Number	121151-30A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on risk management and clinical evaluation this case is considered as closed.
Event or Problem Description
(b)(4).From initial user´s narrative: found leak from the hub of the spinal needle while injecting the mix of local anaesthetic and opioids.No injury.

• Brand Name: SPROTTE
• Common Device Name: ANAESTHESIA CONDUCTION NEEDLE, SPINAL
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• MDR Report Key: 6896817
• Report Number: 9611612-2017-00009
• Device Sequence Number: 11068615
• Product Code: BSP
• UDI-Device Identifier: 14048223000653
• UDI-Public: 14048223000653
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2017

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: Physician
• Device Expiration Date: 07/05/2022
• Device Model Number: 121151-30A
• Device Catalogue Number: 121151-30A
• Device Lot Number: 1214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/27/2017
• 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