MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® EPIDURAL MINIPACK; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number 100/391/126

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation in to this complaint is limited as no sample is available for analysis.Review of the photographs provided by the customer show leakage of blood at the insertion site as described by the customer however without the device to analyse it is not possible to determine any cause related to the epidural minipack components.A review of the device history records shows no issues were recorded during manufacture of these devices.Therefore this complaint cannot be confirmed at this time.A review of previous complaints shows that there have been no previous reports received of an issue of this nature.

Event Description

It was reported that after the catheter of a portex® epidural minipack was inserted, blood oozed from the puncture site.It was reported the event occurred immediately upon use of the device.The device was able to be kept in place and was used successfully.No injury was reported.

• Brand Name: PORTEX® EPIDURAL MINIPACK
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; 1 st. crispin way; haslingden; rossendale, lancashire, BB4 4 PW,; UK BB4 4PW,
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis,, MN 55442
• MDR Report Key: 7550598
• MDR Text Key: 109501176
• Report Number: 3012307300-2018-10020
• Device Sequence Number: 1
• Product Code: BSO
• 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,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/16/2019
• Device Catalogue Number: 100/391/126
• Device Lot Number: 2726767
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2015
• Initial Date FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1