MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX® EPIDURAL MINIPACKS; ANESTHESIA CONDUCTION KIT

Catalog Number 922/016/0585

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and 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 the portex® catheter broke while removing the device from the patient.According to the reporter, 5 cm of the catheter remained inside the patient.According to the reporter, the event occurred during administration of a thoracic epidural on a "difficult" patient who was undergoing a laparoscopic hemi colectomy.It was reported that the clinician "struggled" to position the epidural catheter successfully through the epidural needle and the needle and catheter were removed together.It was reported that while attempting to remove the catheter, the clinician experienced difficulty and encountered "lots of resistance and it was not straight forward." upon the removal of the needle and catheter it was observed that the end of the catheter was missing.It was reported that the epidural was completed successfully with a new kit in a different position.According to the reporter, the patient underwent a computerized tomography (ct) scan and magnetic resonance imaging (mri) to locate the catheter fragment that remained in the patient; however, the fragment could not be located.It was reported that advice from a neurosurgeon was being sought; however, no additional information was provided regarding the appointment.According to the reporter, the patient was monitored; however, no further actions were performed.It was reported that the epidural components were disposed of.

• Brand Name: PORTEX® EPIDURAL MINIPACKS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.,; 52 grayshill road; cumbernauld, glasgow G68 9 HQ; UK G68 9HQ
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6280508
• MDR Text Key: 65849300
• Report Number: 3012307300-2017-00213
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 922/016/0585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR