MAUDE Adverse Event Report: BECTON, DICKINSON & CO. SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number 400866

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/27/2020

Event Type  malfunction  

Event 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10539831
• MDR Text Key: 207187913
• Report Number: 10539831
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904008666
• UDI-Public: (01)00382904008666(17)211031(10)0001345574
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400866
• Device Lot Number: 0001345574
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA
• Patient Weight: 60