MAUDE Adverse Event Report: HALYARD HEALTH MIC* TJ FEEDING TUBE KIT 16 FR, 22CM (ENDO/RADIOL); DIGESTIVE HEALTH ENTERAL FEED DEVICE TUBE KITS

Model Number 0250-16-22

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

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

Event Date 04/13/2015

Event Type  malfunction  

Event Description

It was reported that during a tube check on the g port and the jejunal port of the transgastric device, the jejunal port was found to be leaking into the patient's stomach.After the jejunal tube was removed, the port was tested and seemed to be leaking at a transition point just distal to the retention balloon.This was discovered before the patient left the lab and another device was placed.Additional information was received on (b)(6) 2015 from the customer that the "leak" was noted under fluoroscopy when the tube patency was checked.The tube was removed and another tube placed without any significant delay in the procedure with no injuries to the (b)(6).

Manufacturer Narrative

No known impact or consequence to patient, (b)(4), device code: leak, (b)(4), device code: burst, (b)(4), the actual complaint product was returned for evaluation.The sample was received with an extension set attached to the jejunal feeding port.The original packaging was not returned with the device.The duck bill valve was viewed under magnification, and it was slightly open.Although the balloon was not specifically mentioned in the original report, visual evaluation of the returned device found that the balloon was burst.A syringe was attached to the feed port and water was flushed through the pressurized feed lumen, no leakage or inter lumen communication observed; therefore, we were unable to duplicate the reported failure.A review of the device history record is in-progress and follow-up report will be filed.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).

Manufacturer Narrative

The device history records for the reported lot number aa4265n39 were reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The device history records for the lot number of the returned device aa4160n40 were reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.One sample device was returned.The original packaging was not returned with the device.An extension set was attached to the jejunal feed port on the enteral feeding tube.The duck bill valve was viewed under magnification, and it was slightly open.The balloon was deflated a syringe was attached to the both the jejunal and gastric feed ports and water was flushed through the pressurized feed lumens, no leakage or interlumen communication was observed in either of the lumens.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).

• Type of Device: DIGESTIVE HEALTH ENTERAL FEED DEVICE 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 84048 840; MX 84048 8404
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 4770317
• MDR Text Key: 20752149
• Report Number: 9611594-2015-00064
• 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
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0250-16-22
• Device Catalogue Number: 991095482
• Device Lot Number: AA4265N39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• 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
• Patient Age: 3 YR