MAUDE Adverse Event Report: HALYARD HEALTH MIC* TJ FEEDING TUBE KIT 18 FR, 45CM (ENDO/RADIOL); DIGESTHEALTH ENTERAL FEED TUBE KITS

Model Number 0250-18

Device Problems Complete Blockage (1094); Hole In Material (1293)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided, and a root cause could not be determined.Halyard health 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 halyard health complaint database and identified as complaint (b)(4).Device not returned.

Event Description

It was reported by the customer that the transgastric jejunal feeding tube was split and the jejunal portion was clogged.There was no patient injury reported and no adverse event reported.Additional information was received on (b)(6) 2016 from the customer that states, the transgastric jejunal feeding tube was a routine procedure exchange, without incident.No additional information was provided.

Manufacturer Narrative

The sample was received and evaluated.The molded head appears to be clean without any foreign substance on the exterior of the device while the tube and the balloon appears to be discolored with foreign substances on the exterior and interior of the device.A 1.2cm split was observed in the area of the gastric lumen.The original packaging was not returned with the device.The balloon was filled with 7cc of water and was observed for leaks.No leakage was detected from the balloon or balloon inflation port.The balloon was manipulated in order to try and identify a leaking area on the device.No leakage was observed.The gastric tube was examined under magnification (30x), it showed signs of damage/splitting approximately 8mm just below the molded head.The gastric lumen was then filled with water and then methylene blue.The fluids both exited to the area of splitting and the designed skive location.The jejunal port was infused with water also for flushing, there were no signs of clogging or blockage on the tubes as the water was extracted and the feed port filled methylene blue to give a clearer fluid pathway.It was showed that there was no clogged or blockages in the jejunal lumen since the methylene blue only exited the designed skive in the specified location.The reported event of blockage could not be confirmed.A split in the gastric lumen was confirmed, but with no root cause identified.The manufacturing process was reviewed, and nothing was found that could have contributed to this type of failure.The device history record for the lot number, aa5264n19, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.Halyard health 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 halyard health complaint database and identified as (b)(4).

• Type of Device: DIGESTHEALTH ENTERAL FEED TUBE KITS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V.; circuito industial no.40; colonia obrera; nogales, mexico
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5571871
• MDR Text Key: 43034400
• Report Number: 9611594-2016-00060
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 0250-18
• Device Catalogue Number: 991095484
• Device Lot Number: AA5264N19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 70