MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE 2.G; SPINAL NEEDLE

Model Number 021251-29A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6), and has been reported through (b)(4) distribution subsidiary pajunk medical produkte gmbh.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).Cannula in patient broken.

Manufacturer Narrative

Event took place in germany and has been reported through (b)(4).Based on rik assessment and clinical assessment this file is considered as closed.

Event Description

Irn#: (b)(4).Cannula in patient broken.

• Brand Name: SPROTTE 2.G
• 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: 10374686
• MDR Text Key: 231722629
• Report Number: 9611612-2020-00010
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223024307
• UDI-Public: 14048223024307
• 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: 09/01/2020

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: 021251-29A
• Device Catalogue Number: 021251-29A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other