MAUDE Adverse Event Report: NULL PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C45101344-NLJ

Device Problem Break (1069)

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

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

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.The sample was visually inspected at a distance of 12" under normal lighting to received unit, in order to detect any damage on the unit.The elbow is broken.The reported issue is confirmed.Relevant documents which were reviewed and deemed adequate and correct with respect to testing and inspection activities.Based on the analysis conducted in the sample provided, the failure could not be reproduced, therefore according with the pfmea the occurrence for this failure condition could be caused by: material damage during process handling.All mitigations on placed were verified and it was confirmed that it has been executing according, therefore no corrective actions could be implemented, this failure condition will be monitor in this product for threshold or escalation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.

Event Description

It was reported that during a pre-use check, the customer noticed the gas sampling port was broken.No patient injury was reported.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 15410904
• MDR Text Key: 305893773
• Report Number: 3012307300-2022-18947
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Expiration Date: 12/16/2022
• Device Catalogue Number: C45101344-NLJ
• Device Lot Number: 3923191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1