MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q ANTIMICROBIAL EXPANSION KITS WITH SILVERSOAKER CATHETER 5 IN; CATHETERS

Model Number	PM020-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no information provided regarding the return of the actual complaint product to the manufacturer.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 28-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).
Event or Problem Description
It was initially reported that a catheter broke.Additional information received on 04-aug-2017 stated that the catheter broke off when the nurse attempted to remove it from a patient.As a result, the patient had to return to surgery for removal of the broken segment.It was noted that there was no difficulty experienced when inserting the catheter.It was secured with tegaderm and dressing, and pouch for ball.During removal, the resistance met on a scale of 0-5 was a 5, and the break had a clean cut appearance.It was stated that no permanent injury occurred to the patient.Medwatch report mw5071292 was received on 16-aug-2017.

• Brand Name: ON-Q ANTIMICROBIAL EXPANSION KITS WITH SILVERSOAKER CATHETER 5 IN
• Common Device Name: CATHETERS
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6828424
• Report Number: 2026095-2017-00161
• Device Sequence Number: 489180
• Product Code: BSO
• UDI-Device Identifier: 30680651135354
• UDI-Public: 30680651135354
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/04/2017

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: Nurse
• Device Model Number: PM020-A
• Device Catalogue Number: 101353500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 08/29/2017
• Patient Sequence Number: 1