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

Model Number	8270-16-1.5-30
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter's profession: health professional.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.All information reasonably known as of 18 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).
Event or Problem Description
It was reported that the jejunal lumen in the device had a hole in it which allowed the feed to enter the stomach instead of the jejunum.The tube was replaced.Per additional information received 10 jul 2018, there was no injury to the patient as a result of the issue.
Additional Manufacturer Narrative
Correction: based on the sample received, the model number, catalog number and udi have been updated.The device history record for lot aa7051n27 was reviewed and the product was produced according to product specifications.All information reasonably known as of 01 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).
Additional Manufacturer Narrative
The device history record for lot aa7051n27 was reviewed and the product was produced according to product specifications.All information reasonably known as of 01 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).
Additional Manufacturer Narrative
The sample evaluation confirmed the jejunal and gastric lumens had torn which allowed for an inner lumen crossover; however, there were no activities or tools that could cause this type of flaw in the tube component; the cause for this incident could not be conclusively determined.All information reasonably known as of 11-sep-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: 7711530
• Report Number: 9611594-2018-00103
• Device Sequence Number: 920533
• Product Code: KNT
• UDI-Device Identifier: 10680651470383
• UDI-Public: 10680651470383
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2018

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
• Device Expiration Date: 02/01/2019
• Device Model Number: 8270-16-1.5-30
• Device Catalogue Number: 104408500
• Device Lot Number: AA7051N27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/16/2018; 08/16/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/01/2018; 09/11/2018
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 13