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

Model Number	121251-30A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 took place in (b)(6) and has been reported through (b)(4) distributor (b)(4).
Event or Problem Description
(b)(4).From initial reporter´s narrative: when using the product the injection plastic part on the needle suddenly falls of.Parts of the needle was still in the patient's back.The doctor could get the needle without harming the patient.
Event or Problem Description
Irn# 560_155-18.From initial reporter´s narrative: when using the product the injection plastic part on the needle suddently falls of.Parts of the needle was still in the patiens back.The doctor could get the needle without harming the patient.
Additional Manufacturer Narrative
Based on risk management assessment and clinical evaluation report this file is considered as closed.- attachment: [2018-09-20_560_155-18_9611612-2018-00024fu_report.Pdf].

• Brand Name: SPROTTE 2.G
• Common Device Name: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 07; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7513611
• Report Number: 9611612-2018-00024
• Device Sequence Number: 1528797
• Product Code: BSP
• UDI-Device Identifier: 14048223024376
• UDI-Public: 14048223024376
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: Other Health Care Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: 121251-30A
• Device Catalogue Number: 121251-30A
• Device Lot Number: 1237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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