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

Model Number	42-2438
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/12/2017
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 not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 08-aug-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).Device not returned.
Event or Problem Description
It was reported that the patient's nasogastric (ng) tube was removed due to a nasal sore.When the ng tube was removed, however, no resistance was felt during flushing.However, the hospital staff noted that the entire tube was not removed, and 25cm was still in the patient.A small amount of feed was reported to be in the patient's mouth on occasion.When the medical staff was informed, an x-ray was reviewed.The patient was required to have a scope to remove the remainder of the tubing.No further information was provided.
Additional Manufacturer Narrative
All information reasonably known as of 11-sep-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).

• Brand Name: HALYARD CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6783770
• Report Number: 3009124963-2017-00038
• Device Sequence Number: 13845655
• Product Code: KNT
• UDI-Device Identifier: 10815149020553
• UDI-Public: 10815149020553
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K821906
• 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
• Report Date (Section B): 08/24/2017

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: Health Professional
• Device Model Number: 42-2438
• Device Catalogue Number: 104607900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 09/18/2017
• Patient Sequence Number: 1