MAUDE Adverse Event Report: NULL PORTEX EPIDURAL FLAT FILTER WITH NRFIT CONNECTOR;; ANESTHESIA CONDUCTION KIT

Lot Number 200603

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 07/01/2020

Event Type  malfunction  

Event Description

It was reported that prior to opening package, dust was found on airway circuit.No patient injury was reported.

Manufacturer Narrative

Catalog number is unknown.Udi information is unknown.Operator of device is unknown.No information has been provided to date.Manufacturing site address is unknown.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 and functional testing were performed.It was confirmed that there were two small brown substances in total on the flexible tube and inside the package.The root cause of the reported issue was not identified.The following causes are considered as possible root cause: foreign matter was attached to the product supplied from the overseas manufacturer; foreign matter has adhered during the domestic manufacturing process; foreign matter has entered the package hole after product shipment.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX EPIDURAL FLAT FILTER WITH NRFIT CONNECTOR
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15410208
• MDR Text Key: 306273362
• Report Number: 3012307300-2022-18901
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172410
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 200603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2022
• 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