MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX CONTINUOUS EPIDURAL TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number 4935MP-17

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found the first photo shows a fragment of the tray lid and the second photo shows the tray with two components.One of the components appeared to be compromised.Evaluation of the provided samples with unaided eye found two devices, one of the devices was observed to be broken and the wire was stretched.Review of the bill of material for tray part and the set up picture, included in device history record (dhr) found no components that could be matched with the returned samples.These samples do not resemble the needle nor the catheter from the affected tray.The provided samples are not provided as a part of the tray.The root cause of the reported issue was found to be not relevant to this manufacturer medical product.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

Event Description

It was reported a continuous epidural that staff stated unwound.No patient injury was reported.

• Brand Name: PORTEX CONTINUOUS EPIDURAL TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15311632
• MDR Text Key: 305355021
• Report Number: 3012307300-2022-16523
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 4935MP-17
• Device Lot Number: 4009465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1