MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIEC

Catalog Number C37101329-NLJ

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, the breathing bag was found partially torn.No patient involvement.No additional information is available for this complaint.

Event Description

It was reported that during the pre-use check, the breathing bag was found partially torn.No patient involvement.No additional information is available for this complaint.

Manufacturer Narrative

Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly and packaging process.Therefor the damage (broken) was after the product left shm facilities.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIEC
• Manufacturer (Section G): NULL
• MDR Report Key: 13604035
• MDR Text Key: 286256022
• Report Number: 3012307300-2022-04172
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C37101329-NLJ
• Device Lot Number: 20713423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1515-2021, Z-1516-2021
• Patient Sequence Number: 1