MAUDE Adverse Event Report: KING SYSTEMS UNIVERSAL FLEX2 CIRCUIT; ANESTHESIA CIRCUIT

Catalog Number DF375-6121Z

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2012

Event Type  malfunction  

Event Description

Gas sampling luer fitting on elbow of anesthesia circuit broke during use.No adverse events associated with malfunction reported.See scanned page.

• Brand Name: UNIVERSAL FLEX2 CIRCUIT
• Type of Device: ANESTHESIA CIRCUIT
• Manufacturer (Section D): KING SYSTEMS; noblesville IN
• Manufacturer Contact: 15011 herriman blvd.; noblesville, IN 46060 ; 3177763175
• MDR Report Key: 4012559
• MDR Text Key: 21492644
• Report Number: 1824226-2014-00002
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: DF375-6121Z
• Device Lot Number: I02IV
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2012
• Initial Date FDA Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1