MAUDE Adverse Event Report: SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number	400866
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Incident description: failed spinal - positive cerebrospinal fluid (csf) aspiration, 1.8ml 0.75% marcaine, 200 mcg duramorph, 10 mcg fentanyl given after positive csf aspiration.After medications were injected, again positive aspiration was noted as well.Spinal not adequate for surgery - general anesthesia needed.0.75% marcaine, manufactured by baxter, lot# a0c0091.Note from the operative report: "the patient was taken to the operating room where spinal anesthesia was administered, but was not adequate to control the pain.She had to be converted to general." there were no complications noted.Note: the top label of the package was not saved; unknown manufacturer of spinal tray.The side of the spinal tray had the reference numbers but no product name.

• Brand Name: SPINAL ANESTHESIA TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10539831
• Report Number: 10539831
• Device Sequence Number: 11373974
• Product Code: CAZ
• UDI-Device Identifier: 00382904008666
• UDI-Public: (01)00382904008666(17)211031(10)0001345574
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/10/2020
• Report Date (Section F): 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 400866
• Device Lot Number: 0001345574
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Weight: 60
• Date Report Sent to FDA: 09/10/2020