MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* GASTRIC-JEJUNAL FEEDING TUBE KIT, SECUR-LOK* EXTENSION SETS; DH EF BALLOON TUBES PRODUCTS

Model Number	0270-16-1.7-45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code: patient required hospitalization one used sample without original packaging was returned for evaluation.Per visual inspection, the molded head, tube, and balloon appeared to be discolored with foreign substances on the exterior of the device.The balloon was filled with 5 cc of water and observed, and no leakage was detected from the balloon or inflation port.The balloon was manipulated in order to try and identify a leaking area and no leakage was observed.The area where the jejunal port was located was examined under 30x magnification, and evidence of a tear or split on the silicone molded head area was observed.There was adhesive residue on this area as well.No root cause could be identified.There is no way of knowing the conditions to which the device was subjected to during use.The device history record for the reported lot number was reviewed and the product was produced according to product specifications.The manufacturing process was examined and no abnormalities were detected during the process assessment.All information reasonably known as of 21 jul 2017 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
It was reported that the junction where the gastro-jejunal tube connected with the external connector broke within three months of use.The feeding tube was changed.Per additional information received on 4 jul 2017 that because of the break, the patient required an overnight stay in a hospital and an iv.Per additional information received on 6 jul 2017, the break was internal on the tube, and no broken pieces were inside the patient.The iv was given to the patient as no feeding could be done until the feeding tube could be exchanged.No additional information has been received at this time.

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6749988
• Report Number: 9611594-2017-00111
• Device Sequence Number: 670241
• Product Code: KNT
• UDI-Device Identifier: 10680651956382
• UDI-Public: 10680651956382
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K926581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2017

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: Other
• Device Expiration Date: 01/01/2018
• Device Model Number: 0270-16-1.7-45
• Device Catalogue Number: 991095638
• Device Lot Number: AA6013N21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/28/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention