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

Model Number	511151-29A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Event took place in spain.Based on risk assessment and clinical assessment this file is considered as closed.
Event or Problem 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
• Common Device Name: SPINAL NEEDLE, SINGLE USE
• MDR Report Key: 12030752
• Report Number: 9611612-2021-00010
• Device Sequence Number: 4165962
• Product Code: BSP
• UDI-Device Identifier: 04048223066898
• UDI-Public: 04048223066898
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2025
• 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
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 10/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other