MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX® CONTINUOUS EPIDURAL TRAY; PERIFIX 17 GA. EPIDURAL NEEDLE

Model Number CE17TKFCS

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem Headache (1880)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample, a thorough sample analysis could not be performed and no specific conclusions can be drawn.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or involved needle material number.There were no other reports of this nature against the reported lot number.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by the user facility: reports experiencing issues with blocked epidural needles.In one case, a wet tap occurred.The patient who experienced the wet tap was an ob patient in labor.The patient was in her 20's and was of normal weight.A labor epidural was being performed where no loss of resistance was achieved.The crna went through the epidural space to the spinal space waiting to feel loss of resistance.This never occurred because the needle was not patent.The crna pulled out the needle and tried to flush it with normal saline without success.The crna then tried to thread the catheter through the needle with no success.A new tray was then opened, and the epidural went in without a problem.There was never any csf in the tuohy needle, but the patient experienced a headache after delivery and had to have a blood patch for headache relief.

• Brand Name: PERIFIX® CONTINUOUS EPIDURAL TRAY
• Type of Device: PERIFIX 17 GA. EPIDURAL NEEDLE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5402036
• MDR Text Key: 37242199
• Report Number: 2523676-2016-00007
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: CE17TKFCS
• Device Catalogue Number: 332097
• Device Lot Number: 0061460422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2015
• 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