MAUDE Adverse Event Report: SPROTTE; SPINAL NEEDLE

Model Number 021163-29A

Device Problems Loss of or Failure to Bond (1068); Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2021

Event Type  malfunction  

Manufacturer Narrative

Event took place in the (b)(6).Currently the available data is poor.As soon as further information is available, an additional report will be sent in to the agency.

Event Description

Irn#: (b)(4).After normal spinal injection, at the moment of removing the needle from the patient, the needle broke up (hub broke off from the actual needle) i had to pull out part of the needle manually from the patient.No injury sustained.No further action required.

Manufacturer Narrative

Event took place in the (b)(6).Based on risk assessment and clinical evaluation report this failure is estimated to be an isolated individual event.This file is considered as closed.

Event Description

Irn#: (b)(4).After normal spinal injection, at the moment of removing the needle from the patient, the needle broke up (hub broke off from the actual needle) i had to pull out part of the needle manually from the patient.No injury sustained.No further action required.

• Brand Name: SPROTTE
• Type of Device: SPINAL NEEDLE
• MDR Report Key: 11617410
• MDR Text Key: 243925882
• Report Number: 9611612-2021-00004
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04048223052679
• UDI-Public: 04048223052679
• Combination Product (y/n): N
• PMA/PMN Number: K160295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

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 Expiration Date: 09/02/2022
• Device Model Number: 021163-29A
• Device Catalogue Number: 021163-29A
• Device Lot Number: 1344
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• 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): Other; Required Intervention