MAUDE Adverse Event Report: KIMBERLY-CLARK HEALTH CARE MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 16 FR, 1.7 CM, 30 CM; ENTERAL FEEDING TUBE

Model Number 0270-16-1.7-30

Device Problems Fluid/Blood Leak (1250); Split (2537)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

Kimberly-clark received a report from the (b)(6) stating, "the transgastric tube was successfully placed and the girl was discharged home that afternoon.However, she was then readmitted during the night of thursday, (b)(6) 2014, last week with a suspected blocked tube, but when it was imaged, it was found to be split and leaking.I ordered another one and this was replaced early this week.She is a child who has very complex respiratory problems and every day of admission requires a high dependency unit bed." kimberly-clark has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the kimberly-clark complaint database and identified as complaint (b)(4).

Manufacturer Narrative

We are unable to review the device history record as no lot number was provided for the device involved in this reported event.The device was not returned to kimberly-clark for evaluation, therefore we are unable to determine a root cause for the reported event.Information from this incident will be included in our product complaint and mdr trend reporting systems.Ongoing analysis of trend information is used to identify the need for additional investigations.Device not returned by customer.

• Type of Device: ENTERAL FEEDING TUBE
• Manufacturer (Section D): KIMBERLY-CLARK HEALTH CARE; 1400 holcomb bridge road; roswell GA 30076
• Manufacturer (Section G): NOGALES 1/AVENT 1; carretera intn'l salida norte; #1053; magdelena sonora 8416 ; MX 8416
• Manufacturer Contact: ra/qa ae coordinator ; 1400 holcomb bridge road; roswell, GA 30076
• MDR Report Key: 3938509
• MDR Text Key: 4571951
• Report Number: 9611594-2014-00059
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 0270-16-1.7-30
• Device Catalogue Number: 991095637
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1