MAUDE Adverse Event Report: WILSON-COOK MEDICAL, INC. PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number W3543719

Device Problem Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 05/30/2015

Event Type  malfunction  

Event Description

While trying to place a peg, the physician attempted to place blue plastic "wire" into opening made with needle into stomach.The blue "wire" would not move from the casing.It usually comes out very easily.She tried pulling and twisting casing,then popped the casing apart and it still would not move.

• Brand Name: PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL, INC.; 4900 bethania station road; winston-salem NC 27105
• MDR Report Key: 5263241
• MDR Text Key: 32590636
• Report Number: 5263241
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/01/2016
• Device Lot Number: W3543719
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 73