MAUDE Adverse Event Report: SPROTTE NRFIT; SPINAL NEEDLE

Model Number	051163-29A
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6).As soon as further information becomes available a follow up report will be sent in to the agency.
Event or Problem Description
Irn# (b)(4).Nrfit packet contained a non nrfit spinal needle.Anaesthetist was unable to administer block without removing and changing the spinal needle.Narrative from the cer: the hospital have converted to nrfit.They use nrfit sprotte.They opened a box of nrfit sprotte needles in theatres, opened the packet, took the needle out, inserted it into the patient, and found the nrfit syringe wouldnt connect.On closer inspection, they found this needle to be a luer sprotte.Staff then opened another box and found 1 x more unit of a luer sprotte, in a nrfit sprotte box.Hence the 2 x lot numbers.Theatre staff on site disposed of the needles into the sharps bin.
Event or Problem Description
Irn# (b)(4).Nrfit packet contained a non nrfit spinal needle.Anaesthetist was unable to administer block without removing and changing the spinal needle.Narrative from the cer: the hospital have converted to nrfit.They use nrfit sprotte.They opened a box of nrfit sprotte needlesin theatres, opened the packet, took the needle out, inserted it into the patient, and found the nrfit syringe wouldnt connect.On closer inspection, they found this needle to be a luer sprotte.Staff then opened another box and found 1 x more unit of a luer sprotte, in a nrfit sprotte box.Hence the 2 x lot numbers.Theatre staff on site disposed of the needles into the sharps bin.
Additional Manufacturer Narrative
Event took place in the uk.As soon as further information becomes available a follow up report will be sent in to the agency.Based on risk assessment and clinical assessment this file is considered as closed.

• Brand Name: SPROTTE NRFIT
• Common Device Name: SPINAL NEEDLE
• MDR Report Key: 11234658
• Report Number: 9611612-2021-00001
• Device Sequence Number: 4371759
• Product Code: BSP
• UDI-Device Identifier: 14048223026981
• UDI-Public: 14048223026981
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 03/30/2025
• Device Model Number: 051163-29A
• Device Catalogue Number: 051163-29A
• Device Lot Number: 1343
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 04/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• 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; Required Intervention