MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD., PORTEX® EPIDURAL MAXIPACK; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number 100/390/118

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193)

Event Date 06/04/2016

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

The event occurred in (b)(6).The customer reported that the patient entered the hospital on (b)(6) 2016 and was discharged on (b)(6) 2016.Patient entered hospital for labor and delivery and there was an attempt for epidural analgesia in labor using the portex epidural maxipack.Anaesthetist started catheter insertion aseptically.After confirming epidural space, she inserted the catheter in the space to a length of 15cm.Aspiration of the catheter was negative for cerebral spinal fluid.There was some blood coming out of suggestive of intravascular placement.Anaesthetist attempted withdrawal of the epidural needle along with the catheter and the catheter got cut at the 8cm mark.A neurosurgeon met with the patient and advised for mri but it was unable to view the epidural catheter because it was less than 1mm in diameter.A ct scan thoraco lumbar spine also failed to reveal the catheter.No evidence of dura being punctured, cerebrospinal fluid leak or indentation on dural sac.No additional medical treatment was performed on patient.Unknown patient condition at this time.

Manufacturer Narrative

The reported 18g epidural catheter vestamidtip was returned for investigation.The returned device consists of one epidural product; which was received in used conditions and without its original packaging.Visual inspection was at a distance of 12" to 24" and normal conditions of illumination and the tip of the closed end of the catheter was broken.The complaint was confirmed; root cause is unknown.

• Brand Name: PORTEX® EPIDURAL MAXIPACK
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.,; 52 grayshill road; cumbernauld, glasgow G68 9 HQ; UK G68 9HQ
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.,; 52 grayshill road; cumbernauld, glasgow G68 9 HQ; UK G68 9HQ
• Manufacturer Contact: lisa perz ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5806616
• MDR Text Key: 49920677
• Report Number: 2183502-2016-01534
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K062005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 100/390/118
• Device Lot Number: 2969149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• 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): Required Intervention