MAUDE Adverse Event Report: HALYARD HEALTH DIGESTHEALTH ENTERAL FEED TUBE KITS; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	7170-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual sample is available but has not be returned yet.Upon completion of the investigation; a 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 complaint (b)(4).Device not returned.
Event or Problem Description
It was reported that, when pulling through the peg tube, it broke and the part of the tube with the bumper obstructed the patient's airway and her oxygen level immediately started to decrease rapidly.The doctor quickly went in and pushed it out of the airway and into the esophagus, then had to get a device to pull it out.No additional information available for this report.

• Brand Name: DIGESTHEALTH ENTERAL FEED TUBE KITS
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6394584
• Report Number: 3006646024-2017-00004
• Device Sequence Number: 650793
• Product Code: KNT
• UDI-Device Identifier: 30680651409783
• UDI-Public: 30680651409783
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2017

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: 08/31/2018
• Device Model Number: 7170-20
• Device Catalogue Number: 104097800
• Device Lot Number: 0202586087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 64