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

Catalog Number C37101307J

Device Problem Leak/Splash (1354)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, leakage of air from a pinhole in the product was observed.No patient involvement.No additional information is available.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Sample received: one (1) sample was returned for evaluation from p/n 450952-nl, the returned sample was received inside a plastic bag without its original packaging.Visual inspection: the sample was visually inspected: results: breathing filter is loose from adult tube bushing.Breathing filter test: iso tapered fitting insertion force: size 22mm need to be inspected with a minimum and maximum force (10.11 lbs ? 12.41 lbs) / current sample result: taper verification of the pieces are not accepted with a minimum force of 10.1 lbs.Conclusions: based on the visual and dimensional results the nonconformance reported as breathing filter is confirmed due dimensional issue on the breathing filter.Other analysis: base on the assembly revision the issue reported could not be reproduced in the manufacturing process since this breathing filter is provided by the supplier.Per occurrence review as dimensional issue in the breathing filter an escalation with the supplier was performed to investigate and determine the root cause.Escalation was initiated on december 9th, 2021, under (b)(4) the cause of the reported problem could not be determined.Lots 4112669 was manufactured with (b)(4) units; lots met the requirements to release with no deviations identified during their manufactured.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 14043854
• MDR Text Key: 288801828
• Report Number: 3012307300-2022-05974
• 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
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

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 Operator: Health Professional
• Device Catalogue Number: C37101307J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1