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	04/29/2017
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 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 comp-(b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.
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 first of two reports.Refer to 3009124963-2017-00024 for the second 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 tip of the device for insertion of the tube.There was no reported injury.

• 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: 6616086
• Report Number: 3009124963-2017-00023
• Device Sequence Number: 926411
• 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
• Report Date (Section B): 05/09/2017

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 Model Number: 20-9366AIV2
• Device Catalogue Number: 104578600
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 06/06/2017
• Patient Sequence Number: 1
• Patient Age: 16 MO
• Patient Weight: 8