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

Catalog Number 4986-18/27

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.This complainant reports the device came from one of the two noted lots below: lot # 3209485; device manufacture date: 07/19/2016; expiration date: 10/31/2017.Lot # 3209259; device manufacture date: 05/16/2016; expiration date: 10/31/2017.Device evaluation in progress.

Event Description

It was reported the portex® csecure® catheter was placed for a vaginal delivery on (b)(6) 2016 and it was removed with no difficulty on (b)(6) 2016, however it was noted upon removal the tip was not 'blue' and measured 3 cm short.It is also reported that on (b)(6) 2016 the patient underwent a spinal x-ray and no radiopaque catheter was noted in the epidural space.The same day a lumbar computerized tomography (ct) was done to evaluate if the catheter could be found and 'no part of the catheter was able to be found in the patient'.It is also reported 'the product did not cause or contribute to patient or clinical injury'.

Manufacturer Narrative

One portex® catheter and an attached epifuse® connector were returned for investigation; the epidural needle was not returned.The device was received outside its original packaging.Photographs were also provided for review.Visual inspection of the returned device revealed that the patient end (tip) of the catheter was missing.Upon further examination of the compromised end of the catheter, it was found that the observed cut was clean.Without the return of the epidural needle, investigation of the returned device and review of the provided photograph was unable to determine the root cause of the catheter severance.

• Brand Name: PORTEX® COMBINED SPINAL EPIDURAL ANESTHESIA TRAYS
• 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 ASD INC.,; 10 bowman drive; keene NH 03431
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6224250
• MDR Text Key: 63910286
• Report Number: 3012307300-2017-00015
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 4986-18/27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 23 YR
• Patient Weight: 98