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

Model Number	8140-16-2.0
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device code: unknown balloon issue.The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 26-oct-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 by the distributor (b)(4) that the patient experienced a peritoneal extravasation four days after placement.There was an unknown problem with the balloon.No further information has been provided to halyard at this time.
Additional Manufacturer Narrative
The device history record for (b)(4) was reviewed and the product was produced according to product specifications.One used sample was returned for evaluation, along with an extension set.Both the mic key device and extension set was noted to have a white powdery substance inside the lumens.During the decontamination process, this substance was flushed out.The balloon of the mic key was filled with 5cc water and was observed for leaks.No leakage was detected from the balloon or balloon inflation port, even after squeezing and manipulating the balloon.The water was removed, and the balloon was refilled with methylene blue and to sit on a blotter for 30 minutes.After 30 times, there was no visible leakage of methylene blue.No device malfunction could be detected.No root cause for the reported event could be determined.All information reasonably known as of 16-nov-17 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 (b)(4).

• Brand Name: MIC-KEY GASTROSTOMY FEEDING TUBE EXTENSION SETS WITH ENFIT CONNECTOR
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6984688
• Report Number: 9611594-2017-00146
• Device Sequence Number: 18943697
• Product Code: KNT
• UDI-Device Identifier: 10680651427462
• UDI-Public: 10680651427462
• 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): 11/01/2017

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: 01/01/2019
• Device Model Number: 8140-16-2.0
• Device Catalogue Number: 104274600
• Device Lot Number: AA7024F08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 11/21/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other