MAUDE Adverse Event Report: KIMBERLY-CLARK HEALTH CARE MIC PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 0170-20

Device Problems Bent (1059); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 03/17/2014

Event Type  malfunction  

Event Description

While the sheath was being removed from a trocar needle to advance it into the patient's abdomen, there was a bent piece of plastic.This peg kit was then deemed unusable and a new kit had to be opened and used to complete the procedure.

• Brand Name: MIC PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): KIMBERLY-CLARK HEALTH CARE; 1400 holcomb bridge road; roswell GA 30076
• MDR Report Key: 3702885
• MDR Text Key: 15104582
• Report Number: 3702885
• Device Sequence Number: 1
• Product Code: KNT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 0170-20
• Device Lot Number: 0201039872
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2014
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR