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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. ESPOCAN® COMBINED SPINAL/EPIDURAL TRAYS Back to Search Results
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.
 
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Brand NameESPOCAN® COMBINED SPINAL/EPIDURAL TRAYS
Type of DeviceSPINAL/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 Key5390222
MDR Text Key36893266
Report Number2523676-2015-00697
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K932400
Number of Events Reported1
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 Received01/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2017
Device Model NumberES1725KFX
Device Catalogue Number333196
Device Lot Number0061450447
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/26/2016 Patient Sequence Number: 1
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