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

Model Number	450952-NL
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was in use with patient and leakage was noted.No adverse effects to patient reported.
Additional 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 or Problem Description
Investigation completed and summarized in h 10.

• Brand Name: PORTEX
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10755147
• Report Number: 3012307300-2020-10768
• Device Sequence Number: 4282972
• Product Code: CAI
• UDI-Device Identifier: 15019315075834
• UDI-Public: 15019315075834
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1