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

Model Number	405637
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Correction: c.1 there was no adverse drug event.The suspect products were erroneously submitted.
Event or Problem 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
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10471336
• Report Number: 1625685-2020-00079
• Device Sequence Number: 11360741
• Product Code: CAZ
• UDI-Device Identifier: 00382904056377
• UDI-Public: 00382904056377
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 0001332520
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/08/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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: Other