MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number 450952-NL

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2020

Event Type  malfunction  

Event Description

It was reported the device was in use with patient and leakage was noted.No adverse effects to patient reported.

Manufacturer Narrative

Other, other text: investigation completed on a smiths breathing|portex general anesthesia circuits.Pictures were received and observe that that a sample p/n 450952-nl, l/n 3918232, the sample was received in used conditions without their original packaging.Sample had pinhole.During functional testing the device did not pass the circuit test leak.Complaint confirmed.Capa 000415 was opened on 22/dec/2017, in order to determine the root cause and implement proper corrective actions for leaking.By the time this report has been completed 10/nov/2020 capa 000415 status is in implementation phase.Corrective actions will be addressed on capa 000415.

Event Description

Investigation completed and summarized in h 10.

• Brand Name: PORTEX
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10755147
• MDR Text Key: 213658404
• Report Number: 3012307300-2020-10768
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 15019315075834
• UDI-Public: 15019315075834
• Combination Product (y/n): N
• PMA/PMN Number: K002506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/04/2022
• Device Model Number: 450952-NL
• Device Catalogue Number: 450952-NL
• Device Lot Number: 3918232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1