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

Model Number 405637

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

Suspect products name and strength: bupivacaine hcl (0.75%) with dextrose (8.25%), 2 ml (marcaine).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 the patient didn't not receive adequate anesthesia from tray spn spt24g3.5 l/b-d/e for the procedure.This was discovered during use.The following information was provided by the initial reporter: material no.405637 batch no.0001332520.It was reported that the marcaine in the spinal tray is compromised.Event description per email states: there is concern that these lots have issues with the marcaine that is supplied in the trays.There have been a few reports.Pt scheduled for c/section this am was positioned for a spinal in or.Dr.Administered spinal anesthesia without difficulty, was confident in placement.Patient did not receive adequate anesthesia to proceed with c/section, case was converted to general anesthesia and proceeded without incident.Dr.Was concerned that this is the second such case in 36 hours.He had the same incident on a patient on 6/14 at 2100.Again, dr.Was confident the placement was appropriate, but patient did not receive adequate anesthesia for the procedure and required general anesthesia.Dr.Is concerned that the marcaine in the spinal trays is compromised.

Manufacturer Narrative

Correction: c.1 there was no adverse drug event.The suspect products were erroneously submitted.

Event Description

It was reported that the patient didn't not receive adequate anesthesia from tray spn spt24g3.5 l/b-d/e for the procedure.This was discovered during use.The following information was provided by the initial reporter: material no.405637, batch no.0001332520.It was reported that the marcaine in the spinal tray is compromised.Event description per email states: there is concern that these lots have issues with the marcaine that is supplied in the trays.There have been a few reports.Pt scheduled for c/section this am was positioned for a spinal in or.Dr.Administered spinal anesthesia without difficulty, was confident in placement.Patient did not receive adequate anesthesia to proceed with c/section, case was converted to general anesthesia and proceeded without incident.Dr.Was concerned that this is the second such case in 36 hours.He had the same incident on a patient on 6/14 at 2100.Again, dr.Was confident the placement was appropriate, but patient did not receive adequate anesthesia for the procedure and required general anesthesia.Dr.Is concerned that the marcaine in the spinal trays is compromised.

• Brand Name: TRAY SPN SPT24G3.5 L/B-D/E
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10471336
• MDR Text Key: 205467509
• Report Number: 1625685-2020-00079
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056377
• UDI-Public: 00382904056377
• Combination Product (y/n): Y
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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: 0001332520
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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): Other