MAUDE Adverse Event Report: ST PAUL PORTEX; EPIFUSE

Catalog Number 100/391/116CZ

Device Problem Fracture (1260)

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

Event Date 07/28/2021

Event Type  malfunction  

Event Description

Information received a smiths medical pain management|portex epidural continuous trays has broken epifuse.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated after device evaluation h10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.One used decontaminated sample cp1690 catheter connector 19-21g(us) 16-18g(smi) epifuse epidural - luer was received for investigation without its original packaging.Under visual inspection we noticed that connector has broken hinge.Smiths medical received several customer complaints describing cp1690 hinge break.Scar00171-cz was raised against supplier mar-lee in (b)(6) 2017.Supplier recommended a redesign of the hinge area.Complaint trend was escalated to business unit level and the issue is currently monitored by trend tnd-00035.The cause of the reported problem was traced to the third party supplied item.

Manufacturer Narrative

Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-09108.The report was submitted in error., corrected data: corrected information provided in h10.

• Brand Name: PORTEX
• Type of Device: EPIFUSE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12415139
• MDR Text Key: 269578600
• Report Number: 3012307300-2021-09108
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/391/116CZ
• Device Lot Number: 4067835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1