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

Device Problem Contamination (1120)

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

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be performed.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found a part of the female connector of the flat filter (the base of the lug) was whitened.During functional testing water was injected by connecting a syringe, but no leakage was found at the connection, so it is considered that the connector was not deformed or damaged.Since only the root of the lug is whitened, it is considered that it is not a reaction by a chemical solution but an excessive force.The root cause of the reported issue was found to be user interface.We will record the occurrence of this event in a database, monitor the occurrence tendency of this event, and take appropriate measures according to the occurrence situation.No product information has been provided to date.(b)(4).

Event Description

It was reported that after passing medical fluid (physiological saline solution and popscaine) through the product using a syringe, the customer noticed the filter's connection part got whitened by crystal-like substance.No patient injury was reported.

• Brand Name: PORTEX CONTINUOUS EPIDRUAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15327592
• MDR Text Key: 305421904
• Report Number: 3012307300-2022-16653
• 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: 08/31/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 08/31/2022
• 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