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

Model Number 511151-29A

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 06/07/2021

Event Type  malfunction  

Event Description

(b)(4) tentative summarizing translation from initial reporter´s narrative: "the incident have been reported by an anesthetist from (b)(6).According to the reporter, after performing a spinal puncture, the needle separated from the cone.This issue was notified to the hospital purchasing department." cer: the outer cannula of the 25gx90cm pajunk sprotte needle was detached from the connector itself.There was no incidence in the patient.A sample unit is available to send to the supplier.The client reports on (b)(6) 2021 that when removing the needle after performing a spinal puncture, he disassembled from the cone.The procedure could be carried out without problem and it is reconfirmed that the incident had no impact on the patient.Emails with the client are attached.

Manufacturer Narrative

Event took place in (b)(6).Currently the data available is poor.As soon as we we will receive an update a supplemental report will be sent in to the agency.

Manufacturer Narrative

Event took place in spain.Based on risk assessment and clinical assessment this file is considered as closed.

Event Description

Irn# 160-21_729 tentative summarizing translation from initial reporter´s narrative: "the incident have been reported by an anesthetist from hospital (b)(6).According to the reporter, after performing a spinal puncture, the needle separated from the cone.This issue was notified to the hospital purchasing department." cer: the outer cannula of the 25gx90cm pajunk sprotte needle was detached from the connector itself.There was no incidence in the patient.A sample unit is available to send to the supplier.The client reports on (b)(6), 2021 that when removing the needle after performing a spinal puncture, he disassembled from the cone.The procedure could be carried out without problem and it is reconfirmed that the incident had no impact on the patient.Emails with the client are attached.

• Brand Name: SPROTTE
• Type of Device: SPINAL NEEDLE, SINGLE USE
• MDR Report Key: 12030752
• MDR Text Key: 281147210
• Report Number: 9611612-2021-00010
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04048223066898
• UDI-Public: 04048223066898
• Combination Product (y/n): N
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 511151-29A
• Device Catalogue Number: 511151-29A
• Device Lot Number: 1378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• 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