MAUDE Adverse Event Report: COOK COOK; RING BILIARY DRAIN 10 FRENCH

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/13/2017

Event Type  Injury  

Event Description

Pt had a retained plastic stiffener after a biliary drain exchange.The tip of the plastic stiffener and the tip of the catheter are the same color."is the product compounded: no; is the product over-the-counter: no.".

• Brand Name: COOK
• Type of Device: RING BILIARY DRAIN 10 FRENCH
• Manufacturer (Section D): COOK
• MDR Report Key: 6903618
• MDR Text Key: 87860726
• Report Number: MW5072533
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Weight: 73