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

Model Number 071151-30A

Device Problems Break (1069); Entrapment of Device (1212); Fracture (1260)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 03/09/2018

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 103086414
• Report Number: 9611612-2018-00021
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223000615
• UDI-Public: 14048223000615
• Combination Product (y/n): N
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention