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

Model Number	7170-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was 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
It was reported by a nurse that, "during placement of the peg tube, while pulling the tapered tip of the tube through the abdominal wall, the white strain relief connection portion of the tube lodged in the wall of the abdomen, snapping apart from the bumper portion of the tube.Attempts to retrieve the separated piece with a snare via endoscopy were unsuccessful, therefore an incision was made in the abdomen to expose and retrieve the separated piece.The placement of the tube was then completed with the internal bumper placed against the stomach wall." there was no reported injury and there was no further incident.Additional information was received on 02-feb-2017 that states, "while attempting to pull the peg tube up from the stomach through the abdominal with the physician holding tension, the peg tube separated at the white heat seal with the implant portion of the peg retained in the patient¿s tissue.The bumper was visualized in the stomach with the egd scope.The physician attempted to retrieve the white bumper of the peg kit using multiple devices and was unsuccessful in retrieving the peg tube.The physician then decided to use a forcep at the incision site and was able to open the incision site and grasp the corner of the retained heat seal and pull the implant portion of the peg tube up successfully through the stomach wall and tissue and complete the peg tube placement without any further incident.".
Additional Manufacturer Narrative
The sample was returned for evaluation.One (1) used sample was returned without the original packaging; however, the sample was returned with a product labeling.The separated component was returned with the device as well.The returned device was reviewed under magnification.The peg assembly did not have the bumper returned with the device.There was a separation of the tubing at the heat shrink (white) area.The barbed connector appeared to be damaged when looking under magnification (30x).The device history record (dhr) for the lot number involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.There were no nonconformance(s), or abnormal conditions noted at the time of production.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.There was no definitive root cause determined.All information reasonably known as of 26jun2017 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Brand Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Common Device Name: DIGESTHEALTH ENTERAL FEED TUBE KITS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6330503
• Report Number: 3006646024-2017-00003
• Device Sequence Number: 799003
• Product Code: KNT
• UDI-Device Identifier: 30680651409820
• UDI-Public: 30680651409820
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

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: 02/28/2018
• Device Model Number: 7170-24
• Device Catalogue Number: 104098200
• Device Lot Number: 0202463584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2017
• Supplement Report FDA Received Date: 06/29/2017
• Patient Sequence Number: 1
• Patient Age: 70 YR