MAUDE Adverse Event Report: HALYARD HEALTH, INC MIC TRANSGASTRIC - JEJUNAL FEEDING TUBE KIT; ENTERAL FEEDING TUBE

Model Number 0250-22

Device Problems Hole In Material (1293); Leak/Splash (1354); Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

This is the third of three reports for the same pt involving three separate products.Refer to mfr report number 9611594-2014-00156 for the first report.Refer to mfr report number 9611594-2014-00157 for the third party.It was reported by a nurse that a pt experienced three enteral feeding tube device failures within three months.Each enteral feeding tube lasted a month before it developed a pinhole and leaked.The hole was usually on the j-portion of the enteral feeding tube.The nursing staff states that the tubes will usually clog prior to failure.The pt was getting continuous feedings with an add'l bag of water to flush the tube every six hours.The staff was crushing the medications prior to infusing in the enteral feeding tube.The nurses have started using a lipase enzyme in the enteral feeding tube to prevent clogging of the tube.According to the nurse, the lipase enzyme will prevent clogging of the tube until the hole developsand the tube fails.There was no reported pt injury but the pt required medical intervention to replace the tube under fluoroscopy.The stoma site remained open and intact at the thime of the event.No add'l info was provided in regards to the pt's status and the outcome of the procedure.

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for eval.A review of the device history record is not possible as no lot number was provided.Halyard health has no independent knowledge of the event reported but is relaying the info that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(6).

• Brand Name: MIC TRANSGASTRIC - JEJUNAL FEEDING TUBE KIT
• Type of Device: ENTERAL FEEDING TUBE
• Manufacturer (Section D): HALYARD HEALTH, INC; alpharetta GA 30004
• Manufacturer (Section G): AVENT S.DE R.L. DE C.V.; circuito industial no.40; nogales sonora 8404 8; MX 84048
• Manufacturer Contact: lisa clark ; 5405 winward pkwy; alpharetta, GA 30004
• MDR Report Key: 4289041
• MDR Text Key: 5196351
• Report Number: 9611594-2014-00158
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0250-22
• Device Catalogue Number: 991095487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR
• Patient Weight: 40