MAUDE Adverse Event Report: HALYARD HEALTH CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR; DH CPK NG TUBES

Model Number	42-9368
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
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 in-progress.All information reasonably known as of 29-nov-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.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 an incident occurred in the intensive care unit (icu) department regarding a nasogastric (ng) feeding tube breaking inside of a patient.The patient was sitting in the hospital bed at time issue occurred.No additional information was provided.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
All information reasonably known as of 20-dec-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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
Review it was determined that this was a duplicate complaint, reported previously under 3009124963-2017-00055.Going forward, all additional information will be provided on follow ups to 3009124963-2017-00055.No further information will be provided for this report.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7076578
• Report Number: 3009124963-2017-00056
• Device Sequence Number: 1275332
• Product Code: KNT
• UDI-Device Identifier: 20815149020673
• UDI-Public: 20815149020673
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K821906
• 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): 12/06/2017

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 Model Number: 42-9368
• Device Catalogue Number: 104609201
• Device Lot Number: 78594
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 12/22/2017
• Patient Sequence Number: 1