MAUDE Adverse Event Report: HALYARD HEALTH LAPAROSCOPIC INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE; DH EF PERC PLACEMENT PRODUCTS

Model Number	10226
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 28aug2017 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).
Event or Problem Description
Call from physician reporting "2 sutures broke from the placement kit, it appears the break is proximal to the t-bar.I placed the tube and t-fasteners yesterday on a (b)(6) female and this morning on rounds two of the 3 sutures were broken.The 3 cm of suture was still attached to the clip, which is approx.Length of the stoma, i feel as though the suture is not strong enough to support the normal skin swelling that comes from new placement of the tube.There was no patient injury and the tube appeared to be intact and in the correct position.".
Additional Manufacturer Narrative
All information reasonably known as of 28sep2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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: LAPAROSCOPIC INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6837199
• Report Number: 9611594-2017-00123
• Device Sequence Number: 13595544
• Product Code: KGC
• UDI-Device Identifier: 10680651102260
• UDI-Public: 10680651102260
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2017

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: Physician
• Device Model Number: 10226
• Device Catalogue Number: 991010226
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 09/29/2017
• Patient Sequence Number: 1
• Patient Age: 61 YR