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

Catalog Number 100391118CZ

Device Problem Positioning Problem (3009)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was a significant increase in accidental dural punctures due to placement of the epidural catheter from a portex epidural minipack during labor analgesia.No reported adverse events.

Manufacturer Narrative

One un-opened epidural minipack system ((b)(4)) was received in a plastic bag for investigation.The investigation site received a different lot number than the one reported by the customer in the original complaint.The customer reported lot #3518001, however lot #3404459 was received by the investigation site.Under visual inspection the samples appeared to be in good condition.The components were connected together and flushed with water.No issue were found in this test.This test was followed by an inspection of the epidural catheter and tuohy needle.These components were inspected because only these two parts might have caused the reported dura punctures.The epidural catheter was inspected and was found to be acceptable.A catheter dimensional measurement was done on shadowgraph g:00005.The catheter dimensions were measured on three positions close to the tip.The measurements provided below were found to be within specifications.(b)(6).The tuohy needle was inspected on tensometer g:00678-cz and g:00129 as part of the needle penetration test.The test measurements were within specification (specification 0.5n - 3.0n, measured value 1.0n).The possible root cause was attributed to the following: "rotating the epidural needle while in the epidural space may tear or puncture the dura mater.".

• Brand Name: PORTEX® EPIDURAL MINIPACK
• Type of Device: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC; olomoucka 306; hranice, 753 0 1; EZ 753 01
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7278366
• MDR Text Key: 100464890
• Report Number: 3012307300-2018-00278
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2022
• Device Catalogue Number: 100391118CZ
• Device Lot Number: 3518001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• 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