MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 16 FR, 2.0 CM, 30 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0270-16-2.0-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for aa6144n21 was reviewed and the product was produced according to product specifications.All information reasonably known as of 26 jun 2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.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 or Problem Description
It was reported that the patient's mother tried to connect the feed to the transgastric-jejunal tube and noted that the external portion of the tube was lying in the patient's lap and the remainder of the tube was no longer visible, and assumed to be inside the patient's stomach.The patient was brought to hospital and an x-ray confirmed that the tube was in the stomach and small bowel.Approximately 30cm of tubing had broken off into the patient's gi system.An interventional radiology procedure was unsuccessful at retrieving the device.A new device was placed and daily x-rays were performed to track the progress of the broken tubing.The patient successfully passed the tube unassisted and was discharged home.No residual effects reported.Per additional information received on 12 jun 2017, it is unknown how long the tube was in use prior to breakage.The time it took for the patient to pass the device was 3 days.
Additional Manufacturer Narrative
One used device was returned for evaluation.The returned sample was damaged, and the molded head of the mic-key gj was not returned.The balloon could not be filled for testing due to the separation under the molded head.Instead, the balloon was blown up with air to show the appearance of the balloon fabric.The balloon fabric did not appear altered.The sample was visually inspected, and it was noted that the molded head (not returned) had separated from the feeding tube.The separation site exhibited a tearing effect at the bonded location where the components are joined.Under 50x magnification, the site of the tear appeared jagged.The tube length and french size were measured and found to be within specifications.The reported event was confirmed by sample evaluation.The manufacturing process was reviewed, and no process could be identified that would cause the damage observed on the sample.No root cause could be identified.All information reasonably known as of 17-oct-17 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6678809
• Report Number: 9611594-2017-00093
• Device Sequence Number: 11277741
• Product Code: KNT
• UDI-Device Identifier: 10680651956405
• UDI-Public: 10680651956405
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K926581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/01/2018
• Device Model Number: 0270-16-2.0-30
• Device Catalogue Number: 991095640
• Device Lot Number: AA6144N21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 10/17/2017
• Patient Sequence Number: 1
• Patient Age: 1 MO