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

Model Number 405672

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 08/11/2020

Event Type  Injury  

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 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.

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 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10617134
• MDR Text Key: 209839193
• Report Number: 1625685-2020-00091
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: (01)00382904056728
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 405672
• Device Catalogue Number: 405672
• Device Lot Number: 0001283016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2019
• 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; Required Intervention