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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. PORTEX® CONTINUOUS EPIDURAL TRAY ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD INC. PORTEX® CONTINUOUS EPIDURAL TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number A4219-17
Device Problem Material Integrity Problem (2978)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/05/2016
Event Type  malfunction  
Manufacturer Narrative
Lot number: potential lot number: 3232471. Expiration date: for potential lot number: 05/31/2018. Device manufacturer date: for potential lot number: 06/17/2016. Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
It was reported that a portex continuous epidural tray was used in an epidural procedure where the end of a catheter sheared off and was left in the epidural space of a patient. The procedure was performed by a resident-in-training and observed by the attending staff anaesthesiologist. When the catheter was inserted through the epidural needle into the epidural space, the resident-in-training encountered resistance and pulled the catheter back while still in the needle. The catheter and needle were removed and it was noticed that the most distal end of the catheter (about 0. 5cm to 1. 0cm) was sheared off. A ct scan showed the foreign body left in the epidural space. The severed catheter was discarded. No adverse health outcomes were detected by physician.
 
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Brand NamePORTEX® CONTINUOUS EPIDURAL TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
lisa perz
1265 grey fox rd.
st. paul, MN 51122
7633833074
MDR Report Key5969858
MDR Text Key55433868
Report Number2183502-2016-02018
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K965017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberA4219-17
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 Received08/24/2016
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 Unkown

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