MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ESPOCAN® COMBINED SPINAL/EPIDURAL TRAYS

Model Number ES1725KFX

Device Problems Sticking (1597); Unintended Movement (3026)

Patient Problems Cerebrospinal Fluid Leakage (1772); Burning Sensation (2146); Needle Stick/Puncture (2462)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.The event description indicated that the lor glass syringe did not slide smoothly despite lubrication with saline solution, which altered sensation during lor technique, resulting in an inadvertent dural puncture and leakage of csf.However, without the actual sample, a thorough evaluation 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 nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or involved lor syringe 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 through medwatch # (b)(4): "while doing a routine combined spinal epidural, glass syringe malfunctioned by not sliding easily even though it was completely lubricated with sterile saline throughout the barrel from the cse kit.This resulted in alteration of sensation of the bouncing of the plunger when advancing the tuohy needle and ultimately inadvertent dural puncture and leakage of csf from the tuohy needle.Attempted to thread the epidural catheter into the subdural space to leave in for 24 hours to decrease risk for post-puncture headache but patient began to complaint of paresthesias on the right, so the catheter and needle were removed completely.".

Manufacturer Narrative

Per follow-up correspondence with the reporting facility, there were two separate incidents that occurred on the same day with two separate patients (incident # 1 is filed under report # 2523676-2015-00625; incident # 2 is filed under report # 2523676-2015-00697).No samples are available for either occurrence.All available information regarding this occurrence was forwarded to the device manufacturer of the lor glass syringe.The manufacturer performed testing on their retention samples of the involved syringe lots.No issues were found during this testing.All plungers moved freely in and out of the barrels.The manufacturer also indicated that the syringe barrels are siliconized to ensure a smooth plunger flow action, which is designed around a dry prep.If used as a wet prep, as was indicated by the reporting facility, the silicone and saline may create binding.If the syringe sits for an unusual period of time in the wet prep (saline or other solutions), the possibility of binding increases.The saline technique is not recommended with siliconized syringes.Per the instructions for use (ifu) for the saline solution that is provided in b.Braun catalog # 333196, the saline solution is intended to be "used to flush intravascular catheters or as a sterile, isotonic single dose vehicle, solvent, or diluent for substances to be administered intravenously, intramuscularly or sub-cutaneously." if additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: ESPOCAN® COMBINED SPINAL/EPIDURAL TRAYS
• Type of Device: SPINAL/EPIDURAL TRAY
• 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: 5390222
• MDR Text Key: 36893266
• Report Number: 2523676-2015-00697
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: ES1725KFX
• Device Catalogue Number: 333196
• Device Lot Number: 0061450447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2015
• 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
• Patient Age: 28 YR