MAUDE Adverse Event Report: WILSON-COOK MEDICAL DS-60CC-S DILATION SYRINGE G27112

Lot Number W3654009

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  malfunction  

Event Description

Opened the dilation syringe and filled with water.Started to inflate the dilation balloon, but water was leaking around connector.No harm to pt.

• Brand Name: DS-60CC-S DILATION SYRINGE G27112
• Type of Device: DS-60CC-S DILATION SYRINGE G27112
• Manufacturer (Section D): WILSON-COOK MEDICAL; winston-salem NC 27105
• MDR Report Key: 6112678
• MDR Text Key: 60559831
• Report Number: MW5066100
• Device Sequence Number: 1
• Product Code: ILS
• 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: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/25/2018
• Device Lot Number: W3654009
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 91