MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PERIFIX CONTINUOUS EPIDURAL TRAYS; CONTINUOUS EPIDURAL TRAY W/ 18GA NEEDLE

Model Number CE18TKPS

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 08/24/2013

Event Type  Injury  

Event Description

As reported by the user facility through medwatch # (b)(4), "the patient complained of pain at the epidural insertion site following colon resection.Upon physician removal of the catheter, approximately 1 cm of epidural catheter broke off into the epidural space." during follow-up correspondence with the facility, the reporter confirmed that the lot number is unknown and that a sample is not available for evaluation.

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough evaluation could not be performed and no specific conclusion can be drawn.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.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.If additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL TRAYS
• Type of Device: CONTINUOUS EPIDURAL TRAY W/ 18GA NEEDLE
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 3581341
• MDR Text Key: 21267313
• Report Number: 2523676-2013-00433
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CE18TKPS
• Device Catalogue Number: 332216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2013
• 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
• Patient Age: 56 YR
• Patient Weight: 83