MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; SPINAL NEEDLE

Model Number 021151-30C

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

Event took place in the us and has been reported through us distributor distribution subsidiary (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

Irn# (b)(4).Initial reporter´s narrative: needle detached from the hub during spinal insertion remaining in patient back requiring small incision to remove needle remained intact.

Manufacturer Narrative

Event took place in the us and has been reported through us distributor distribution subsidiary pajunk medical systems.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.Based on risk assessment and clinical assessment file is considered as closed.

Event Description

Irn# (b)(4).Initial reporter´s narrative: needle detached from the hub during spinal insertion remaining in patient back requiring small incision to remove needle remained intact.

• Brand Name: SPROTTE
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 9231207
• MDR Text Key: 168456870
• Report Number: 9611612-2019-00033
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223000295
• UDI-Public: 14048223000295
• Combination Product (y/n): N
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

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: Health Professional
• Device Model Number: 021151-30C
• Device Catalogue Number: 021151-30C
• Device Lot Number: 1306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other