MAUDE Adverse Event Report: ST PAUL PORTEX EPIDURAL CONTINUOUS TRAYS; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number 100/391/116CZ

Device Problems Pumping Stopped (1503); Detachment of Device or Device Component (2907)

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

Event Date 06/10/2021

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical epidural was disconnected at the filter attachment with the filter no longer attached to the patient side and the result that epidural infusion stopped.It was removed and alternative post-op analgesia provided.No adverse events reported.

Manufacturer Narrative

Other, other text: d4 (catalog number and udi) and g5 are unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.The customer provided potential lot numbers.No problems or issues were identified during the device history record review.

Event Description

02 jul 2021: additional information received and it's attached.No injuries caused by device.An alternative analgesia provided promptly as soon as pain became an issue the disconnect ion happen between flat filter and yellow connector.The rotating collar was still attached to the filter.The customer checked on the patient records of the affected patients and all had a 16g epidural fitted.The customer took an item from (b)(6) agrees that the item attached was the item with the issue.The issue seems to be from the customer understanding that the screw that connects to the yellow part became disconnected on 3 patients, all with the same size item fitted.

• Brand Name: PORTEX EPIDURAL CONTINUOUS TRAYS
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• 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: 12122416
• MDR Text Key: 262513578
• Report Number: 3012307300-2021-06834
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 05/10/2023

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: Health Professional
• Device Catalogue Number: 100/391/116CZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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