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

Catalog Number C37101329-NLJ

Device Problem Component Missing (2306)

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

Event Date 09/17/2020

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 and picture were received for evaluation.Visual and functional testing were performed.There is one (1) missing tube bushing.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.One (1) tube bushing is missing from the circuit.Relevant documents which were reviewed and deemed adequate and correct with respect to testing and inspection activities.The reported issue was confirmed.A corrective and preventative action has been opened in order to determine the root cause and implement proper corrective actions.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that immediately after opening the package, the customer noticed no 22-mm connector was attached to the product.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: 15416887
• MDR Text Key: 306188310
• Report Number: 3012307300-2022-19054
• 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: 09/14/2022

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
• Device Expiration Date: 04/15/2023
• Device Catalogue Number: C37101329-NLJ
• Device Lot Number: 3973613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1