MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. FLOW 20 PERCUTANEOUS GASTROSTOMY SET; TUBES, GASTROINTESTINAL, SSK

Model Number G56403

Device Problem Difficult to Advance (2920)

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

Event Date 01/11/2017

Event Type  Injury  

Event Description

Involves the portion of the peg tube (the introducer).The physician had difficulty threading a nylon through the introducer resulting in aborting the procedure.May have been secondary to user error but unsure.Manager of endoscopy notified manufacturer.

• Brand Name: FLOW 20 PERCUTANEOUS GASTROSTOMY SET
• Type of Device: TUBES, GASTROINTESTINAL, SSK
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.
• MDR Report Key: 6266370
• MDR Text Key: 65522668
• Report Number: MW5067337
• Device Sequence Number: 1
• Product Code: KNT
• 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: 01/17/2017

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 Model Number: G56403
• Device Lot Number: W3804935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2017
• 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: 58 YR
• Patient Weight: 57