MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	650904
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the seal to a smiths medical portex® adult anesthesia breathing circuit was reported to be leaking.There were no reported adverse effects.

• Brand Name: PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUITS
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis,, mn
• MDR Report Key: 9832658
• Report Number: 3012307300-2020-02021
• Device Sequence Number: 19002662
• Product Code: CAI
• UDI-Device Identifier: 10351688419446
• UDI-Public: 10351688419446
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K002506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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: 10/23/2022
• Device Model Number: 650904
• Device Catalogue Number: 650904
• Device Lot Number: 3898376
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1