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

Model Number 650904

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 02/13/2020

Event Type  malfunction  

Event 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
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis,, mn
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, mn ; 3833310
• MDR Report Key: 9832664
• MDR Text Key: 183479241
• Report Number: 3012307300-2020-02017
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10351688419446
• UDI-Public: 10351688419446
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1