MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX; DISPOSABLE ANESTHESIA BREATHING CIRCUIT ELBOW

Model Number C37031625-NL

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

Disposable anesthesia breathing circuit elbow - unable to connect to circuit due to plastic mold inconsistency.Found prior to use.

• Brand Name: PORTEX
• Type of Device: DISPOSABLE ANESTHESIA BREATHING CIRCUIT ELBOW
• Manufacturer (Section D): SMITHS MEDICAL; keene NH 03431
• MDR Report Key: 3926740
• MDR Text Key: 4494918
• Report Number: MW5037107
• Device Sequence Number: 1
• Product Code: CAI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: C37031625-NL
• Device Lot Number: 2723612
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 17