MAUDE Adverse Event Report: HALYARD HEALTH ENTERAL FEEDING PLACEMENT KIT

Model Number DIGESTHEALTH ENTERAL FEED PERC PLACEMENT

Device Problems Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

During retrospective review on 20mar2017, it was identified that the mdr was incorrectly reported submitted under the incorrect manufacturing site.All information initially submitted under 8030647-2016-00012 is included in this mdr 3006646024 -2017-00008.Corrected manufacturing site information.Corrected typographical error in type of reportable event.(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.Root cause could not be determined.All information reasonably known as of 04apr2017 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).Device not returned.

Event Description

A report was received from france stating that pieces of dilator apparently fell into the stomach of the patient during the removal of the device.Additional information received on 18-jan-2016 stated doctor said that it was a manipulation error.The health care professional removed the piece of the dilator from the patients' stomach.The was no reported injury to the patient.

• Brand Name: ENTERAL FEEDING PLACEMENT KIT
• Type of Device: ENTERAL FEEDING PLACEMENT KIT
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place; suite 100; tucson AZ 85756
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6465014
• MDR Text Key: 71915246
• Report Number: 3006646024-2017-00008
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: DIGESTHEALTH ENTERAL FEED PERC PLACEMENT
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention