MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. CUSTOM EPIDURAL ANESTHESIA TRAY; 19GA FX EPIDURAL CATHETER

Catalog Number 551554

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/13/2014

Event Type  Injury  

Event Description

As reported by the user facility: reports it was noted that 5cm of epidural catheter was left in the patient after undergoing a ct scan for an unrelated reason on (b)(6) 2014.The epidural catheter was placed and removed on (b)(6) 2014.The anesthesiologist stated that it took the catheter, and noted the catheter was removed with "tip intact".The doctor thinks it might have been the centimeter marking on the catheter that the nurse was interpreting as being the blue tip.The patient had a neurosurgical consult, and was advised to leave the catheter fragment in place as the patient was asymptomatic.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report #(b)(4).The actual device involved in the reported incident wa snot returned for evaluation.Without the actual sample or lot number, a thorough evaluation could not be performed and no specific conclusions can be drawn.The event description did indicate that it took three attempts to place the catheter, but it was not clear if resistance was met during removal.While no specific conclusion can be drawn, incidents of this nature can occur when a catheter becomes lodged between rigid body structures and is stretched beyond its design capabilities.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or catheter material number.If additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: CUSTOM EPIDURAL ANESTHESIA TRAY
• Type of Device: 19GA FX EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109-9341 ; 6102660500
• MDR Report Key: 4258860
• MDR Text Key: 20757047
• Report Number: 2523676-2014-00416
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 551554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other