MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* GASTROSTOMY FEEDING TUBE EXTENSION SETS WITH ENFIT CONNECTOR; DH EF BALLOON TUBES PRODUCTS

Model Number	8140-12-0.8
Medical Device Problem Codes	Partial Blockage (1065); Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is not possible as no lot number was provided.Upon completion of the sample evaluation and the investigation; a follow-up report will be filed.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).
Event or Problem Description
It was reported that after 12-days of placement the child was moved in preparation for transport.During the transport of the patient the mic-key device tube snapped.The health professionals tried to replace the mic-key tube but it was impossible because they could not deflate the balloon on the device.The health professionals tried to remove the device three times.On the fourth attempt, they managed to remove 3.9 ml of water.The presence of a white residue which was obstructing the tub was noted.No additional information was provided.
Additional Manufacturer Narrative
One used mickey sample and one syringe filled with 3cc liquid with a bit of white debris floating in it was received.No product packaging was received.The mickey sample appeared in generally clean condition.The mickey was examined and photographed prior to decontamination.No additional white residue was observed.No issues were encountered inflating and deflating the balloon during decontamination and rinse.After decontamination, the sample was examined under magnification.No white residue was found in the inflation port or in the balloon.The balloon was inflated and deflated multiple time without issue.No failure was detected.All information reasonably known as of 04-may-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: 7310741
• Report Number: 9611594-2018-00015
• Device Sequence Number: 19144891
• Product Code: KNT
• UDI-Device Identifier: 10680651426977
• UDI-Public: 10680651426977
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K043114
• 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,Followup
• Report Date (Section B): 04/11/2018

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: Other Health Care Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: 8140-12-0.8
• Device Catalogue Number: 104269700
• Device Lot Number: AA7047F39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 05/04/2018
• Patient Sequence Number: 1
• Patient Age: 9 MO