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

Catalog Number EPX714/118DJP

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).No lot number was provided; therefore, device history record review could not be completed.The device was received for evaluation.Visual testing was performed.Visual inspection, no damage or abnormality was observed in the collar, but the ridge of the flat filter was damaged and flattened.No further functional testing was performed.The root cause of the reported issue was found to be that the collar of the flat filter was easy to come off because the ridge of the flat filter was crushed and flattened.Regarding the flatten of the ridge part, a supplier corrective action has already been issued to the manufacturer.(udi) and report source are unknown.No product information has been provided to date.

Event Description

It was reported that during the use of the product, the luer-lock connector got detached, and the product become disconnected from the epifuse connector.No patient injury was reported.

• Brand Name: PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15634884
• MDR Text Key: 307041871
• Report Number: 3012307300-2022-25192
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EPX714/118DJP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• 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