MAUDE Adverse Event Report: CAREFUSION INC. SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Model Number 400866

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2020

Event Type  malfunction  

Event Description

Incident description: failed spinal - spinal did not fully set up after 20+ minutes.No complications noted with spinal, patient did report feeling some warmth in his legs and tingling in toes, but that is it.Converted to general anesthesia.The procedure was carried out with no complications.Marcaine: mfr: hospira, ndc: 0409-1761-18, lot#: 950953a, expiration date: 11/01/2021.Lidocaine: mfr: hospira, lot#: an1171, expiration date: 01/01/2022.

• Brand Name: SPINAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10747798
• MDR Text Key: 213465305
• Report Number: 10747798
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 10/20/2020

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
• Device Operator: Other
• Device Model Number: 400866
• Device Catalogue Number: 400866
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA