MAUDE Adverse Event Report: B. BRAUN MEDICAL INC PERFIX CUSTOM EPIDURAL TRAY; EPIDURAL CATHETER, CESK

Lot Number 61384766

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/27/2014

Event Type  Injury  

Event Description

Pt presented at 38th week gestation in active labor.Epidural catheter was placed for labor analgesia.When removing needle, epidural catheter was severed leaving 8cm of catheter inside pt.Ct scan indicated that there was a tubular finding to the left of the spinous process at l3.On (b)(6), pt underwent left l3 exploration for removal of the foreign body.

• Brand Name: PERFIX CUSTOM EPIDURAL TRAY
• Type of Device: EPIDURAL CATHETER, CESK
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 824 twelfth ave; bethlehem PA 18018 352
• MDR Report Key: 4270098
• MDR Text Key: 19718744
• Report Number: MW5039140
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 61384766
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 82