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

Model Number	20-9551
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for (b)(4) was reviewed and the product was produced according to product specifications.All information reasonably known as of (b)(6) 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 via the distributor that the feeding tube was removed on 22 nov 2017 and it was noted that approximately (b)(6) was missing from the distal end of the tube.The tube had been placed (b)(6) 2017.No injury to the patient and no medical intervention required.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 17 jan 2018 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).
Additional Manufacturer Narrative
Halyard health received one used sample.No product packaging was received.The product did not contain a lot number identification.The bolus tip was detached from the distal end of the tubing.The bolus tip was not received.The tube length was measured to determine if any portion of the tubing was absent.The tube measured 55 inches from the base of the y-adapter to the distal end.No portion of the tubing is missing.The distal end exhibited discoloration, extending approximately 1.5cm up from the end.In this section, the color was darker and had a more matte finish.The bolus plug separated from the feeding tube.The root cause was attributed to a damaged or broken component.All information reasonably known as of 19-mar-2018 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).

• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7137378
• Report Number: 3009124963-2017-00058
• Device Sequence Number: 1300844
• Product Code: KNT
• UDI-Device Identifier: 10815149023561
• UDI-Public: 10815149023561
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 02/21/2018

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: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 20-9551
• Device Catalogue Number: 104581300
• Device Lot Number: 79342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 12/26/2017; 03/19/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/19/2018; 03/21/2018
• Patient Sequence Number: 1