MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. ESPOCAN COMBINED SPINAL + EPIDURAL ANESTHESIA TRAY

Model Number 333196

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2020

Event Type  malfunction  

Event Description

When removing epidural catheter post delivery noted catheter to be split / torn.Portion removed from pt's back was intact.

• Brand Name: ESPOCAN COMBINED SPINAL + EPIDURAL ANESTHESIA TRAY
• Type of Device: ESPOCAN COMBINED SPINAL + EPIDURAL ANESTHESIA TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL, INC. ; bethlehem PA 18018 3524
• MDR Report Key: 10004485
• MDR Text Key: 190477066
• Report Number: 10004485
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2020

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: No Information
• Device Expiration Date: 01/06/2021
• Device Model Number: 333196
• Distributor Facility Aware Date: 04/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR