MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. ESPOCAN COMBINED SPINAL/EPIDURAL TRAYS; PERIFIX 20 GA. EPIDURAL CATHETER

Model Number ES1827KDS

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/25/2014

Event Type  Injury  

Event Description

As reported by the user facility: reports when the catheter was removed the tip broke off in the pt.Reporter is unaware if there were any problems with the insertion or removal.The catheter did not look stretched.The tip was not surgically removed at this time.

Manufacturer Narrative

This report has been identified as b braun medical inc.(b)(4).One used catheter and one unused catheter were received for eval.The unused catheter appeared intact and no anomalies or fractured ends were visually observed.The used catheter was missing the blue tip and appeared fractured at the tip end.Under microscopic observation, the fractured end appeared stretched and frayed.This type of damage is consistent with epidural catheters in which a section is pulled beyond its design capabilities.This can occur when a catheter becomes lodged between rigid body structures.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this 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 add'l pertinent info becomes available, a f/u report will be filed.

• Brand Name: ESPOCAN COMBINED SPINAL/EPIDURAL TRAYS
• Type of Device: PERIFIX 20 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: 4170271
• MDR Text Key: 5092295
• Report Number: 2523676-2014-00346
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: ES1827KDS
• Device Catalogue Number: 333194
• Device Lot Number: 0061354255
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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): Other