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

Model Number	071151-30A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event took place in (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).Male patient (b)(6).Dr (b)(6) tried to perform a spinal but struggled to get csf and correct placement of the needle.Dr (b)(6) then helped and tried with another needle (its not sure if the needle that snapped was (b)(4)) on performing the spinal the stylet was removed successfully but no csf was found.Spinal needle was removed, on removing it was noticed the end of the needle was missing.X ray was carried out on the patient but could not be found.Ct scan was carried out and the position of the tip identified.Mr (b)(6) vascular surgeon successfully removed the broken needle.
Event or Problem Description
Irn# (b)(4).Male patient bmi 55.Dr (b)(6) tried to perform a spinal but struggled to get csf and correct placement of the needle.Dr (b)(6) then helped and tried with another needle (its not sure if the needle that snapped was 041151-30a or 071151-30a).On performing the spinal the stylet was removed successfully but no csf was found.Spinal needle was removed, on removing it was noticed the end of the needle was missing.X ray was carried out on the patient but could not be found.Ct scan was carried out and the position of the tip identified.Mr (b)(6) vascular surgeon successfully removed the broken needle.
Additional Manufacturer Narrative
Event took place in the uk and has been reported through british distribution subsidiary pajunk medical ltd.Based on risk management file and clinical evaluation report this file is considered as closed.Attachment: [2018-04-16_pn1447b_551_105-18.Pdf].

• Brand Name: SPROTTE
• 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: 7352292
• Report Number: 9611612-2018-00021
• Device Sequence Number: 16571703
• Product Code: BSP
• UDI-Device Identifier: 14048223000615
• UDI-Public: 14048223000615
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

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: 09/18/2022
• Device Model Number: 071151-30A
• Device Catalogue Number: 041151-30A
• Device Lot Number: 1221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/16/2018
• 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