MAUDE Adverse Event Report: HALYARD - IRVINE HALYARD* ON-Q* CATHETERS-SILVERSOAKER*

Model Number	PM010-A
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 used device is reported to be available but has not yet been 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 14-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).Device not returned.
Event or Problem Description
Procedure: knee replacement.Cathplace: both were near knee, surgical sites.It was reported that a patient had dual catheters, one of which came out during patient usage.The patient called the surgeon and instructed the patient to remove the second catheter.The patient kept pulling and met resistance, and it broke.The surgeon order an x-ray and saw a portion of the catheter retained in the patient.The surgeon decided to leave the piece inside the patient for now.

• Common Device Name: CATHETER
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7032744
• Report Number: 2026095-2017-00195
• Device Sequence Number: 13484289
• Product Code: BSO
• UDI-Device Identifier: 30680651135330
• UDI-Public: 30680651135330
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: Lay User/Patient
• Device Model Number: PM010-A
• Device Catalogue Number: 101353300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/15/2017
• Patient Sequence Number: 1