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

Model Number	7180-24
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.A review of the device history record is in-progress.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 (b)(4).Device not returned.
Event or Problem Description
An fda user facility report (b)(4) was received stating , "the gastroenterologist was having trouble pulling the peg tube through during insertion.The numbers on the tube were not showing when the tube met resistance.The tube was pulled harder.Upon checking the peg tube site with the scope, the physician noticed a small tear in the esophagus." no additional information was provided.(b)(4).
Additional Manufacturer Narrative
According to the device history records reviewed for lot number 020240212, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.A sample was not provided for evaluation for this incident; therefore, an evaluation was performed to the assembly process.Controls were in place and all required procedures were followed and this lot met all specifications at product release.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 comp-(b)(4).

• Brand Name: DIGESTHEALTH ENTERAL FEED DEVICE 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: 6275500
• Report Number: 3006646024-2017-00002
• Device Sequence Number: 10963269
• Product Code: KNT
• UDI-Device Identifier: 30680651409837
• UDI-Public: 30680651409837
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/30/2017
• Device Model Number: 7180-24
• Device Catalogue Number: 104098300
• Device Lot Number: 020240212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2017
• Supplement Report FDA Received Date: 03/16/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR