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

Catalog Number 100/391/118CZ

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026)

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

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.Four (4) used decontaminated filters, three (3) used decontaminated connectors and one (1) unopened unit pack samples were received for evaluation.Visual and functional testing were performed.Under visual inspection for used samples, the technician noticed that the rotating collars (luer locks) on flat filters are missing on 3 out of 4 returned filters, 1 rotating collar was still connected with connector.Each flat filter contains retention edge which is designed to hold rotating collar connected with filter.Retention edges on 3 returned samples were found to be damaged and therefore they could not hold rotating collars in place.One flat filter with rotating collar was assembled 10 times with received connectors without any problem.Visual inspection for the unused sample, appeared to be in good condition.Retention ring and luer lock hole diameters were measured under keyence camera system with purpose to find out if there is any dimensional issue which might lead to this customer complaint.Both dimensions were found to be within specifications.The root cause of the reported issue was found to be caused by the user overtightening rotating collar and a supplier corrective action report (scar) was raised in the past against the supplier due to similar customer complaints.Per instructions for use "overtightening the connection between the catheter connector or needle to the male rotating collar may cause rotating collar to dislodge from filter body." no information has been provided to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

Event Description

It was reported that the filter disconnected from the epidural and was found in patient's bed.There was no patient injury reported.

• Brand Name: PORTEX EPIDURAL CONTINUOUS TRAYS
• 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: 15316081
• MDR Text Key: 305355595
• Report Number: 3012307300-2022-16607
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Pharmacist
• 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 Catalogue Number: 100/391/118CZ
• Device Lot Number: 3958253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1