MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 22 FR, 2.7 CM, 45 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0270-22-2.7-45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is reported to be available but was not returned.A review of the device history record is in-progress.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 12-oct-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.(b)(4).
Event or Problem Description
It was reported that medwatch, fda report number fda 3500 form 5071402, was received stating, "patient had existing j tube inserted (b)(6) 2016 in our department.The patient was on our table for replacement (b)(6) 2017 and we discovered that the tube was broken, a scout film before we start and the scout appeared to show a disconnect in the catheter suggestive of a catheter fracture.Sure enough it was fractured and the larger distal portion (essentially the whole tube except for a small portion which goes into the stomach remained) appeared to have migrated into the large bowel.The proximal end of the g-j tube was removed over the wire, but the broken section distally stayed in the bowel general surgery was consulted, but unlikely to have surgical removal based on no sharp edges that could cause perforation." additional information received 11-oct-2017 stated the user reported that the piece that broke off and migrated was determined to not be of any harm to the patient and surgical intervention was not performed.No further information is available on incident or patient status.
Additional Manufacturer Narrative
The device history record for the reported lot number, aa6095n26, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 28-dec-2017 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: 6946175
• Report Number: 9611594-2017-00138
• Device Sequence Number: 899499
• Product Code: KNT
• UDI-Device Identifier: 10680651956740
• UDI-Public: 10680651956740
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K926581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2017

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: Nurse
• Device Expiration Date: 04/01/2018
• Device Model Number: 0270-22-2.7-45
• Device Catalogue Number: 991095674
• Device Lot Number: AA6095N26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 12/16/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 41