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

Catalog Number C37101324-NLJ

Device Problem Defective Device (2588)

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

Event Date 01/27/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the customer noticed a pinhole in the breathing bag.No patient injury was reported.

Manufacturer Narrative

A product sample and pictures were received for evaluation.Visual and functional testing were performed.A tear is observed in the pictures.The sample was received in used conditions without its original packaging.The sample was visually inspected at a distance of 12" under normal lighting to received unit, in order to detect any damaged components.The reported issue was confirmed.The breathing bag had a pinhole.Based on the sample provided, physically evaluation, the most probable cause is 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.Udi is unknown.Operator of device is unknown.Manufacturing site address is unknown.Pma/510k is unknown.This remediation mdr was generated under protocol (b)(4), 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: 15426722
• MDR Text Key: 306070802
• Report Number: 3012307300-2022-19223
• 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: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: C37101324-NLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2022
• 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