MAUDE Adverse Event Report: NULL BREATHING PORTEX GENERAL ANESTHESIA CIRCUITS; ANESTHESIA CONDUCTION KIT

Catalog Number C37101329-NLJ

Device Problem Leak/Splash (1354)

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

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

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 review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.A product sample was received for evaluation.Visual and functional testing were performed.The sample was found to have embedded resin, and the circuit did not pass the leak test.Unable to determine the root cause of the reported issue.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that during pre-use check of product, the customer observed air leaking from the anesthesia circuit.No patient injury was reported.

• Brand Name: BREATHING PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15555294
• MDR Text Key: 306916180
• Report Number: 3012307300-2022-20040
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: C37101329-NLJ
• Device Lot Number: 3959674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• 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