MAUDE Adverse Event Report: B.BRAUN MEDICAL, INC. ESPOCAN 20G CLOSED TIP COMBINED SPINAL EPIDURAL ANESTHESIA TRAY

Model Number 0061615216

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 09/10/2018

Event Type  malfunction  

Event Description

Patient arrived to labor and delivery for c-section. Epidural catheter tip broke off during placement. Dates of use: (b)(6) 2018. The product is not compounded, not otc product; single use.

• Brand Name: ESPOCAN 20G CLOSED TIP
• Type of Device: COMBINED SPINAL EPIDURAL ANESTHESIA TRAY
• Manufacturer (Section D): B.BRAUN MEDICAL, INC.
• MDR Report Key: 7926215
• MDR Text Key: 122624812
• Report Number: MW5080268
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/17/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2019
• Device Model Number: 0061615216
• Device Catalogue Number: 333192
• Device Lot Number: 0061615216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: Yes

Type of Device Usage