MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY JEJUNAL FEEDING TUBE, LOW-PROFILE - 18 FR, 2.7 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0230-18-2.7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Respiratory Distress (2045); Bowel Perforation (2668)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for the reported lot number, aa6256n14, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 06-may-2018 as 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
A report was received stating the patient ended up with a perforation from the device.During insertion the device did not advance far so the physician cut the tube shorter, to about 7 cm, and it perforated the patient's bowel.The physician used a stiff glide and an amplatz (with a 3.5 cm soft tip) for the exchange.It was also a direct stick into the jejunum, not a gastrostomy to jejunum insertion.The patient had to have emergency surgery because the perforation was not found until the next day.The patient was in pain, experienced shortness of breath (sob) and experienced shoulder pain/chest pain.The patient was reported to be doing better since surgery and the device was replaced with just a red rubber catheter.The patient had a t-tube in place prior to the event.No additional information was provided.
Additional Manufacturer Narrative
All information reasonably known as of 19-jun-2018 as 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).

• Brand Name: MIC-KEY JEJUNAL FEEDING TUBE, LOW-PROFILE - 18 FR, 2.7 CM
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7498191
• Report Number: 9611594-2018-00065
• Device Sequence Number: 2211071
• Product Code: KNT
• UDI-Device Identifier: 10680651954753
• UDI-Public: 10680651954753
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K853197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 09/01/2018
• Device Model Number: 0230-18-2.7
• Device Catalogue Number: 991095475
• Device Lot Number: AA6256N14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 06/20/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Weight: 50