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

Model Number	021151-29A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6).Currently the data available is poor.As soon as we will receive an update a supplemental report will be sent in to the agency.
Event or Problem Description
Irn# (b)(4).Tentative summarizing translation from initial reporter¿s narrative: "woman planned for elective cesarean section.Bmi 38 (at the beginning of pregnancy), 150cm long, sharply swaying back.Spinal anesthesia in a sitting position with an angled operating table to optimize that the patient bends his back.Difficult to palpate vertebrae due to obesity and dumb, strong skin.Introducer is introduced without remark.Introduction of spinal sprotte pencil point 25g, 90mm takes place against slightly elevated but constant resistance, gets a "loose" and removes the mandrel to see if liquor exchange, which does not happen.Insert the mandrel again and insert the spinal needle further, the same resistance and now bottoms with the needle in its full length but feel as a contact in depth as in bone contact.Removes mandrang again and looks for liquors, no backflow.The needle gently reverses while checking for liquids.The same tough, constant resistance as with the insertion and when backed 0.5-1 cm, the resistance suddenly releases and the spinal needle brakes inside the patient's back.Has contact with the remaining needle pieces in the introducer, unclear whether in the lumen of the introducer or if the tip touches the broken tip.Unfortunately, the broken piece does not come out and it cannot be palpated in the skin plane.Trying to visualize the needle with ultrasound but it will not be found.The needle parts is removed via surgery.The product with its various parts is saved.".
Additional Manufacturer Narrative
Event took place in sweden.Based on risk assessment and clinical assessment this file is considered as closed.
Event or Problem Description
Irn# (b)(4), tentative summarizing translation from initial reporter´s narrative: "woman planned for elective cesarean section.Bmi 38 (at the beginning of pregnancy), 150cm long, sharply swaying back.Spinal anesthesia in a sitting position with an angled operating table to optimize that the patient bends his back.Difficult to palpate vertebrae due to obesity and dumb, strong skin.Introducer is introduced without remark.Introduction of spinal sprotte pencil point 25g, 90mm takes place against slightly elevated but constant resistance, gets a "loose" and removes the mandrel to see if liquor exchange, which does not happen.Insert the mandrel again and insert the spinal needle further, the same resistance and now bottoms with the needle in its full length but feel as a contact in depth as in bone contact.Removes mandrang again and looks for liquors, no backflow.The needle gently reverses while checking for liquids.The same tough, constant resistance as with the insertion and when backed 0.5-1 cm, the resistance suddenly releases and the spinal needle brakes inside the patient's back.Has contact with the remaining needle pieces in the introducer, unclear whether in the lumen of the introducer or if the tip touches the broken tip.Unfortunately, the broken piece does not come out and it cannot be palpated in the skin plane.Trying to visualize the needle with ultrasound but it will not be found.The needle parts is removed via surgery.The product with its various parts is saved.".

• Brand Name: SPROTTE
• Common Device Name: SPINAL NEEDLE, SINGLE USE
• MDR Report Key: 12030754
• Report Number: 9611612-2021-00011
• Device Sequence Number: 4165963
• Product Code: BSP
• UDI-Device Identifier: 04048223103838
• UDI-Public: 04048223103838
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: 12/07/2025
• Device Model Number: 021151-29A
• Device Catalogue Number: 021151-29A
• Device Lot Number: 1377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• 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