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

Model Number	120066-30A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Nonstandard Device (1420)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in the (b)(6) and has been reported through (b)(6) distribution subsidiary pajunk medical ltd.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).Initial reporter´s narrative: 24g x 90mm sprotte nrfit introduced to subarachnoid space, on injection immediately leaked from side of hub, tried twice with same very obvious result.Needle removed and replaced for use with successful competition.
Additional Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.(b)(4).
Event or Problem Description
Irn# (b)(4).From initial reporter´s narrative: 24g x 90mm sprotte® nrfit introduced to subarachnoid space, on injection immediately leaked from side of hub, tried twice with same very obvious result.Needle removed and replaced for use with successful competition.

• Brand Name: SPROTTE NRFIT
• 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: 7204922
• Report Number: 9611612-2018-00006
• Device Sequence Number: 917241
• Product Code: BSP
• UDI-Device Identifier: 14048223029821
• UDI-Public: 14048223029821
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: Physician
• Device Expiration Date: 07/03/2022
• Device Model Number: 120066-30A
• Device Catalogue Number: 001163-30A
• Device Lot Number: 1213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/23/2018
• 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; Required Intervention