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

Model Number 405637

Device Problem Leak/Splash (1354)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2020

Event Type  Injury  

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 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 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).

Manufacturer Narrative

The following fields have been updated with corrections: g.4.Date received by manufacturer: 2020-09-10.

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 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10564352
• MDR Text Key: 207953244
• Report Number: 1625685-2020-00084
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056377
• UDI-Public: 00382904056377
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention