MAUDE Adverse Event Report:

Device Problems Material Disintegration (1177); Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  Injury  

Event Description

It was reported that during the removal of placental membranes, attempting spinal anesthetic procedure was difficult.Once the procedure was completed it was noted that one of the spinal needles were incomplete.The spinal anesthetic was successful, and removal of the placental membranes was completed.Lumbar x-ray ap and lateral views was taken, which show the spinal needle near the superior articular facet and not in the spinal canal.The patient was schedule to be transfer.Neuro fellow thinks that she does not need any neuro observations and patient can mobilize without any particular restrictions.No adverse patient effects were reported.

• MDR Report Key: 11255601
• MDR Text Key: 229566437
• Report Number: 3012307300-2021-00727
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention