MAUDE Adverse Event Report: TRAY SPN SPT24G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Model Number	405637
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial reporter also notified the fda on 8 june, 2020.Medwatch report # mw5094740 report source other: medwatch report.Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that tray spn spt24g3.5 l/b-d/e needle broke off during injection.The following information was provided by the initial reporter: material no.405637 batch no.0001330369 it was reported that needle broke off during injection.Event description per attached email states: (b)(6) year old female admitted (b)(6) 2020 for pre-eclampsia gestational diabetes management on (b)(6) 2020 due to severe pre-eclampsia goes to operating room for c-section.During spinal epidural tip of needle is noticed to be broken upon removal.Needle send to pathology.The needle was removed (b)(6) by neurologist in the operating room under fluro neurologist signed off (b)(6) the patient discharged (b)(6) she was up ambulating with minimal pain per the md note fda safety report id # (b)(6).
Event or Problem Description
It was reported that tray spn spt24g3.5 l/b-d/e needle broke off during injection.The following information was provided by the initial reporter: material no.405637, batch no.0001330369.It was reported that needle broke off during injection.Event description per attached email states: (b)(6) year old female admitted (b)(6) 2020 for pre-eclampsia gestational diabetes management on (b)(6) 2020 due to severe pre-eclampsia goes to operating room for c-section.During spinal epidural tip of needle is noticed to be broken upon removal.Needle send to pathology.The needle was removed (b)(6) by neurologist in the operating room under fluro neurologist signed off (b)(6) the patient discharged (b)(6) she was up ambulating with minimal pain per the md note fda safety report id # (b)(6).
Additional Manufacturer Narrative
The following fields have been updated with corrections: g.4.Date received by manufacturer: 2020-09-10.
Additional Manufacturer Narrative
Investigation summary : since no samples and no photos were received for evaluation, the investigation was unable to confirm the reported failure mode nor identify any potential issues during manufacture.A probable root cause could not be determined.A review of the device history record noted no issues relating to the reported failure mode for 405637 lot # 0001330369.
Event or Problem Description
It was reported that tray spn spt24g3.5 l/b-d/e needle broke off during injection.The following information was provided by the initial reporter: material no.405637; batch no.0001330369.It was reported that needle broke off during injection.Event description per attached email states: (b)(6) year old female admitted (b)(6) 2020 for pre-eclampsia gestational diabetes management on (b)(6) 2020 due to severe pre-eclampsia goes to operating room for c-section.During spinal epidural tip of needle is noticed to be broken upon removal.Needle send to pathology.The needle was removed (b)(6) by neurologist in the operating room under fluro neurologist signed off (b)(6) the patient discharged (b)(6) she was up ambulating with minimal pain per the md note fda safety report id # (b)(6).

• Brand Name: TRAY SPN SPT24G3.5 L/B-D/E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10564352
• Report Number: 1625685-2020-00084
• Device Sequence Number: 3146237
• Product Code: CAZ
• UDI-Device Identifier: 00382904056377
• UDI-Public: 00382904056377
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2021

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: Other
• Device Expiration Date: 09/30/2021
• Device Model Number: 405637
• Device Catalogue Number: 405637
• Device Lot Number: 0001330369
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 09/10/2020; 02/26/2021
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/03/2020; 03/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2019
• 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: Required Intervention