MAUDE Adverse Event Report: NULL PORTEX CONTINUOUS EPIDURAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number 4509E

Device Problem Break (1069)

Patient Problem Urethral Stenosis/Stricture (4501)

Event Date 09/01/2020

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 testing was performed.Visual inspection found the hinge part of all the connectors were damaged.The root cause of the reported issue was found to be the supplier.An internal scar has been opened.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.Udi, operator of device, and mfr site are unknown.No information has been provided to date this remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Event Description

It was reported that immediately after starting to use the product, the customer noticed the connection part of the epidural connector was broken.No patient injury was reported.

• Brand Name: PORTEX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15315629
• MDR Text Key: 305251721
• Report Number: 3012307300-2022-16586
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K781052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,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 Catalogue Number: 4509E
• Device Lot Number: 200522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2022
• 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