MAUDE Adverse Event Report: CAREFUSION VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT; NONE

Model Number A5U52XX4

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 01/13/2016

Event Type  malfunction  

Event Description

After induction, with the second breast using the rebreather bag, the bag ruptured with large tears in the bag and could not be used any longer.

• Brand Name: VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT
• Type of Device: NONE
• Manufacturer (Section D): CAREFUSION; yorba linda CA 92887
• MDR Report Key: 5394133
• MDR Text Key: 36969970
• Report Number: MW5059669
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A5U52XX4
• Device Lot Number: 0000865274
• Other Device ID Number: 10885403272950
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 115