MAUDE Adverse Event Report: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE; ANESTHESIA CONDUCTION KIT

Model Number	405672
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 2 tray spn whit 25g3.5 l/b-d/e blue drape experienced ineffective anesthesia -treatment failed to work during use.The following information was provided by the initial reporter: material no.405672 batch no.0001283016.Two patients on (b)(6) 2020, received pre-procedure spinal anesthesia which was ineffective and another type of anesthesia had to utilized by the medical provider.Sequestered tray and spinal medication is in the managers office awaiting pick 11p from supply chain.
Additional Manufacturer Narrative
The following information has been corrected: b.1.Adverse type: reported issue is both an adverse event and product problem.B.2.Event attributed to: required intervention.B.5.Describe event or problem: it was reported that 2 tray spn whit25g3.5 l/b-d/e blue drape experienced ineffective anesthesia -treatment failed to work during use.Product defect resulted in medical intervention with a change in treatment, (general anesthesia).The following information was provided by the initial reporter: material no.405672 batch no.0001283016 two patients on 8/11/20, received pre-procedure spinal anesthesia which was ineffective and another type of anesthesia had to utilized by the medical provider.Sequestered tray and spinal medication is in the managers office awaiting pick 11p from s11ppply chain.B.6.Relevant tests/laboratory data: one patient had to have general anesthesia since the spinal did not work.H.1.Type of reportable event: serious injury.
Event or Problem Description
It was reported that 2 tray spn whit25g3.5 l/b-d/e blue drape experienced ineffective anesthesia -treatment failed to work during use.Product defect resulted in medical intervention with a change in treatment, (general anesthesia).The following information was provided by the initial reporter: material no.405672 batch no.0001283016 two patients on 8/11/20, received pre-procedure spinal anesthesia which was ineffective and another type of anesthesia had to utilized by the medical provider.Sequestered tray and spinal medication is in the managers office awaiting pick 11p from s11ppply chain.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10617134
• Report Number: 1625685-2020-00091
• Device Sequence Number: 2630531
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: (01)00382904056728
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• 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): 10/15/2020

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 Model Number: 405672
• Device Catalogue Number: 405672
• Device Lot Number: 0001283016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 10/16/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2019
• 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; Required Intervention