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

Lot Number 3969490

Device Problem Component Missing (2306)

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

Event Date 07/22/2020

Event Type  malfunction  

Event Description

It was reported that a single breathing filter was included in packaging when two were expected.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 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 visually inspected at a distance of 12? under normal lighting to received unit, in order to detect any missing components.It was observed that one filter was included and not the expected 2 filters.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).

• Brand Name: BREATHING PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15464814
• MDR Text Key: 306164563
• Report Number: 3012307300-2022-20091
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• 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: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 3969490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2022
• 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