MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PERIFIX CONTINUOUS EPIDURAL TRAYS; PERIFIX FX 19 GA. EPIDURAL CATHETER

Model Number CE17TKFC

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 04/17/2014

Event Type  Injury  

Event Description

As reported by the user facility through (b)(4): "pt had vaginal delivery (b)(6) 2014 and there was an unsuccessful attempt to remove the epidural catheter post delivery.Required return to operating room for catheter removal by neurosurgeon (tip intact).Pt has persistent back pain that interferes with her attempts to increase activity post delivery.Per the surgeon's report: as epidural was being removed it "fractured" - pt returned to operating room later for an exploration of lumbar spine with left l1-l2 hemilaminectomy for catheter removal.Pre-op asa score 2.".

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for eval.Without the actual sample or lot number, a thorough eval could not be performed and no specific conclusion can be drawn.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 the sample is received for eval or if add'l pertinent info becomes available, a f/u report will be filed.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL TRAYS
• Type of Device: PERIFIX FX 19 GA. EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 3957187
• MDR Text Key: 4608904
• Report Number: 2523676-2014-00241
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CE17TKFC
• Device Catalogue Number: 332079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/20/2014
• 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; Required Intervention
• Patient Age: 29 YR