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

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.

• Brand Name: PORTEX® CONTINUOUS EPIDURAL TRAY
• Type of Device: ANESTHESIA 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 Key: 5969858
• MDR Text Key: 55433868
• Report Number: 2183502-2016-02018
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: A4219-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2016
• 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: Unknown
• Patient Sequence Number: 1