MAUDE Adverse Event Report: ST PAUL PORTEX EPIDURAL CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number 100/391/118CZ

Device Problem Disconnection (1171)

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

Event Date 02/01/2020

Event Type  malfunction  

Event Description

It was reported by the user that when connecting the connector with the filter they noticed the collar of the connector got disconnected.No patient injury was reported.

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.The flat filter was returned with the color removed.An observation of the filter connector showed that the height of the return part of the collar attachment was low and collapsed.The root cause of the reported issue was found to be supplier.We notified the occurrence of this event to our manufacturing department and overseas manufacturers and apply improvement.We will also record this event in the database and monitor the future occurrence situation.D4 unique identifier is unknown.No information has been provided to date this remediation mdr was generated under protocol (b)(6), as a result of warning letter cms# 617147.

• Brand Name: PORTEX EPIDURAL CONTINUOUS TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; kitanagase-omote-machi, kita-; minneapolis, MN 55442
• MDR Report Key: 15316704
• MDR Text Key: 305380873
• Report Number: 3012307300-2022-16632
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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 Catalogue Number: 100/391/118CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• 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