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

Model Number 321151-31A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/23/2021

Event Type  malfunction  

Event Description

(b)(4).Event took place in (b)(6).Cannula broken during use.Part of 5cm remained in pt.Body.Removed under surgical intervention the next day.

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4) distributor.Currently the data available is poor.As soon as further information is received a follow up report will be sent to the agency.

• Brand Name: SPROTTE
• Type of Device: SPINAL NEEDLE, SINGLE USE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 13166895
• MDR Text Key: 286677050
• Report Number: 9611612-2022-00001
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04048223108611
• UDI-Public: 04048223108611
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K911260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 321151-31A
• Device Catalogue Number: 321151-31A
• Device Lot Number: 1392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female