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

Catalog Number 100/391/116

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

One plastic bag with two epifuse connectors and two epidural flat filters were received for investigation.Under visual inspection, we found that one epifuse connector (purchased component) has an uneven split at the hinge line.Since 28-jul-2014 supplier is performing hinge resistance test on one shot every day.The test was repeated on the not broken epifuse connector which was received for this investigation and we can confirm that the sample passed test with no issues.It is the most probable that the affected hinge has not only been open with a torque around the hinge axis, but also off centered from the hinge.Therefore complaint is not confirmed.

Event Description

It was reported that during use of the epidural catheter, connectors were found broken which resulted in leakage.

• 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 ASD, INC.; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 7554284
• MDR Text Key: 109638101
• Report Number: 3012307300-2018-10158
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 100/391/116
• Device Lot Number: 2893513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2016
• 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