MAUDE Adverse Event Report: NEEDLE SPINAL S/SU 20GA 6IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number	405211
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that needle spinal s/su 20ga 6in quincke hub broke.The following information was provided by the initial reporter: plastic needle hub broken so needle wouldn't remain locked for insertion.The plastic needle hub has broken so the needle wouldn't remain locked for insertion.
Event or Problem Description
It was reported that needle spinal s/su 20ga 6in quincke hub broke.The following information was provided by the initial reporter: plastic needle hub broken so needle wouldn't remain locked for insertion.The plastic needle hub has broken so the needle wouldn't remain locked for insertion.
Additional Manufacturer Narrative
H6: investigation: one actual sample was received by our quality team for evaluation.It is observed that the keyway is damaged and does not fit in the keyway slot; therefore, the incident could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the investigation, the most probable root cause for keyway damage condition is regarding the assembly process in the tic machine; in which is used to assemble the stylet to the cannula.

• Brand Name: NEEDLE SPINAL S/SU 20GA 6IN QUINCKE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• MDR Report Key: 11573089
• Report Number: 2618282-2021-00019
• Device Sequence Number: 17009282
• Product Code: BSP
• UDI-Device Identifier: 00382904052119
• UDI-Public: 00382904052119
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 405211
• Device Lot Number: 0041909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2020
• 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