MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* GASTRIC-JEJUNAL FEEDING TUBE KIT - 18 FR, 1.7 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0120-12-1.2
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
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 (b)(6) 2018 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).Device not returned.
Event or Problem Description
It was reported that a tube came out of a stoma site following the removal of gastropexy sutures six days post placement.The tube was replaced by the gastrointestinal nurse, with no issues noted with the balloon at the time of reinsertion.The balloon inflation potentially led to the stomach wall being pushed from the abdominal wall with gastric contents seeping into the peritoneum.An emergency laparotomy was performed.Additional information received on (b)(6) 2018 stated that the button was initially placed by a different doctor.It was placed by securing sutures through the stomach to secure.When the sutures were removed by the current physician, the tube popped out without being manipulated 10 minutes later in the gi clinic.It believed that someone altered the balloon because it had been in place for only six days and was checked beforehand to find no obvious leaks.Attempted button replacement was performed by the gi nurse and this action pushed the stomach wall away, which caused some leaking of gastric contents into the peritoneum.The patient had to go back in for a full emergent laparotomy and open stamm due to this.No further information was received surrounding the event.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 20-jul-2018 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).
Additional Manufacturer Narrative
Halyard health received one used sample.No product packaging was received.The sample was received in generally clean condition, with approximately 2ml clear liquid in the balloon.The balloon inflation port (bip) was examined.The blue plunger actuated upon insertion of the syringe tip.The bip functions as expected.The balloon was filled with 3cc water and was observed for leaks.No leakage was detected from the balloon or balloon inflation port.The balloon was squeezed and manipulated.No leakage was observed.The water was extracted and the balloon was filled with methylene blue.The sample was placed on a blotter and left for a period of 30 minutes.The sample was reevaluated after 30 minutes filled with 3cc methylene blue.There was no visible leakage.The stoma length was measured for comparison to specification.Per specification, the stoma length should be indicated size (1.2cm) +/- 2mm.The stoma length of the returned sample is 1.1cm.The balloon was then filled with 5cc water to replicate the volume mentioned in the complaint description.The symmetry of the balloon was evaluated.When viewed fro the sides, the shape of the balloon did not appear uneven.The symmetry was measured from the distal end.The "zero" point is the center of the feed lumen distal opening.Measurements were taken from left and right of center using a certified center-finding ruler.Side a = 1.0cm; side b = 1.0cm.No functional issue was found on the returned sample.The sample provided was evaluated and no failures were detected in the device returned.Evaluation was unable to confirm or duplicate the reported incident.Root cause could not be determined.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 27-aug-2018 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).

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7617801
• Report Number: 9611594-2018-00074
• Device Sequence Number: 1759696
• Product Code: KNT
• UDI-Device Identifier: 10680651948295
• UDI-Public: 10680651948295
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2018

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 Expiration Date: 09/01/2019
• Device Model Number: 0120-12-1.2
• Device Catalogue Number: 109482907
• Device Lot Number: AA7262F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 07/02/2018; 08/08/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/20/2018; 08/29/2018
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 14