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

Catalog Number C49291349-NLJ

Device Problem Break (1069)

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

Event Date 01/18/2021

Event Type  malfunction  

Event Description

It was reported that during a pre-use check, a crack was found in the breathing circuit.No patient injury was reported.

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be completed.A product sample and pictures were received for evaluation.Visual and functional testing were performed.It was observed in pictures that the circuit had a tear.The sample was received in used conditions without original package.The sample was visually inspected at a distance of 12" under normal lighting to received unit, in order to detect any damage on the units, and the physical evaluation confirmed that the sample unit had a tear.The most probable root cause of the reported issue was found to be that the product became damaged after it left the manufacturing facility.No corrective actions are required since failure mode is not attributable at the manufacturing process since all products are 100% leak tested; if a tear damages a circuit surface couldn?t pass the leak test.Udi is unknown.Operator of device is unknown.Manufacturer site address is unknown.Pma/510(k) is unknown.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 15445789
• MDR Text Key: 305907600
• Report Number: 3012307300-2022-19615
• 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: 09/19/2022

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 Catalogue Number: C49291349-NLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 09/19/2022
• 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