MAUDE Adverse Event Report: HALYARD HEALTH INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE; DIGESTHEALTH ENTERAL FEED PERC PLACEMENT

Model Number 98433

Device Problem Break (1069)

Patient Problem Post Operative Wound Infection (2446)

Event Date 08/15/2017

Event Type  Injury  

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 19oct2017 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).

Event Description

It was reported that the t-fastener broke.Additional information was received on 10-oct-2017 that states, there was a total of four t-fasteners that broke.The first t-fastener broke in the operating room while the patient was being transferred from operating room bed to stretcher.The second t-fastener was found dislodged on pod #1 (the following morning by nursing).The third t-fastener was off the following morning pod #2.The fourth t-fastener was no longer in place while the patient was being brought back to the operating room (morning of pod #3).The patient had significant abdominal wall soft tissue infection that required iv antibiotics and debridement.Also, the patient underwent a second operation to replace his existing j tube, and his abdominal wound required packing which was uncomfortable for the patient.No additional information was provided.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE
• Type of Device: DIGESTHEALTH ENTERAL FEED PERC PLACEMENT
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V.; circuito industrial no. 40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6963355
• MDR Text Key: 89815818
• Report Number: 9611594-2017-00135
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10680651984330
• UDI-Public: 10680651984330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 98433
• Device Catalogue Number: 991098433
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 75