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

Model Number 021151-29A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

Vent took place in (b)(6) and has been reported through (b)(6) distribution subsidiary pajunk medical (b)(4).Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.

Event Description

(b)(4).Summarizing tentative translation of initial reporter´s narrative: upon removal of the spinal needle and the introducer the hub of the introducer came off the needle.

Event Description

Irn# (b)(4).Summarizing tentative translation of initial reporter´s narrative: upon removal of the spinal needle and the introducer the hub of the introducer came off the needle.

Manufacturer Narrative

Vent took place in germany and has been reported through german distribution subsidiary pajunk medical produkte gmbh.Based on risk management and clinical evaluation this file is considered as closed.Attachment: [complaint report for 071-18.Pdf].

• Brand Name: SPROTTE
• Type of Device: ANAESTHESIA CONDUCTION CANNULA, 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: 7295480
• MDR Text Key: 101130832
• Report Number: 9611612-2018-00019
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223000257
• UDI-Public: 14048223000257
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

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: 08/11/2020
• Device Model Number: 021151-29A
• Device Catalogue Number: 021151-29A
• Device Lot Number: 1125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 02/22/2018
• Supplement Dates FDA Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention