MAUDE Adverse Event Report: HALYARD HEALTH CPK CORFLO WITH STYLET; DH CPK ANTI-IV (AIV) FEEDING TUBES

Model Number	20-9366AIV2
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is in-progress.One sample device was returned.There was no evidence that the outer tubing had signs of damage.There were no external dent marks identified after the sample was inspected.The bolus tip and portion of the ng tube were examined under magnification, there were no signs of the tube peeling or damage to the non-weighted bolus.All information reasonably known as of 02-jun-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
Halyard received a single report that referenced 2 different incidences, which were associated with separate units, involving the same patient.This is the second of two reports.Refer to 3009124963-2017-00023 for the first event.A report was received stating the tube is flaking.The flaking fragments were noted in the patient's feces.The parent reports using vaseline at the tipoff the device for insertion of the tube.There was no reported injury.
Additional Manufacturer Narrative
The device history record for the reported lot number, 77534, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.Root cause could not be determined.All information reasonably known as of (b)(4) 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).

• Brand Name: CPK CORFLO WITH STYLET
• Common Device Name: DH CPK ANTI-IV (AIV) FEEDING TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6616089
• Report Number: 3009124963-2017-00024
• Device Sequence Number: 649583
• Product Code: FPD
• UDI-Device Identifier: 20815149023858
• UDI-Public: 20815149023858
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K083210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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: Patient Family Member or Friend
• Device Expiration Date: 03/31/2020
• Device Model Number: 20-9366AIV2
• Device Catalogue Number: 104578600
• Device Lot Number: 77534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 08/04/2017
• Patient Sequence Number: 1
• Patient Age: 16 MO
• Patient Weight: 8