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

Catalog Number 555214

Device Problem Break (1069)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/27/2014

Event Type  Injury  

Event Description

As reported by the user facility through (b)(4): "patient presented at 38th week gestation in active labor.Epidural catheter was placed fro labor analgesia.When removing needle, epidural catheter was severed leaving 8cm of catheter inside patient.Ct scan indicated that there was a tubular finding to the left of the spinous process at l3.Pt underwent left l3 exploration for removal of the foreign body.".

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample, a thorough evaluation could not be performed and no specific conclusions can be drawn.The event description did indicate that the catheter severed when removing the needle.While no specific conclusion can be drawn, incidents of this nature can occur if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of the nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or catheter material number.There were no other reports of this nature against the reported lot number.All available info has been forwarded to the device manufacturer of the catheter.If additional pertinent info becomes available, a follow up report will be filed.

• Brand Name: CUSTOM EPIDURAL ANESTHESIA TRAY
• Type of Device: PERIFIX EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robet hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 4740204
• MDR Text Key: 5702740
• Report Number: 2523676-2015-00145
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 555214
• Device Lot Number: 0061384766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention