MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE 2.G; SPINAL ANAESTHESIA/ LUMBAR PUNCTURE NEEDLE

Model Number	141251-27A
Medical Device Problem Codes	Break (1069); Crack (1135); Fluid/Blood Leak (1250); Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Information (3190)
Date of Event	10/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).From initial reporter's narrative: at the aspiration of the lcr liquid, there is air inside the syringe.At the injection, leakage at the hub.This event occurs at 2 time at 3.
Additional Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
Event or Problem Description
Irn# (b)(4).From initial reporters narrative: at the aspiration of the lcr liquid, there is air inside the syringe.At the injection, leakage at the hub.This event occurs at 2 time at 3.

• Brand Name: SPROTTE 2.G
• Common Device Name: SPINAL ANAESTHESIA/ LUMBAR PUNCTURE NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7005452
• Report Number: 9611612-2017-00011
• Device Sequence Number: 648502
• Product Code: BSP
• UDI-Device Identifier: 14048223022815
• UDI-Public: 14048223022815
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/27/2022
• Device Model Number: 141251-27A
• Device Catalogue Number: 141251-27A
• Device Lot Number: 1199
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 11/24/2017
• 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