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

Catalog Number EPX729/118CJP

Device Problems Leak/Splash (1354); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a fluid leak was noted from the smiths medical portex® epidural.The fluid was noted to be coming from the looped part of the catheter.There was no reported patient complications.

Manufacturer Narrative

One smiths medical portex® epidural was returned for analysis in a used condition.Water was injected into the sample and was confirmed to flow out in two directions; about 2cm from the epifuse connector of the catheter.Two small holes were noted open under visual inspection with a microscope; which appeared from a needle that penetrated the catheter from one hole to the other hole.The hole position was noted where the catheter looped but the elongation of the catheter was not confirmed.Based on the evidence, the complaint was confirmed.However, the root-cause of the holes could not be identified and the failure was a result of the user interfacing with the product in a manner inconsistent with the ifu.

• 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 NIJMEGEN; bijsterhuizen 22 - 08; 6604 ld; wijchen, ; NL
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 7007424
• MDR Text Key: 92172135
• Report Number: 3012307300-2017-02352
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: EPX729/118CJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2017
• 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