MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q ANTIMICROBIAL EXPANSION KITS WITH SILVERSOAKER CATHETER 5 IN (12.5 CM); CATHETERS

Model Number	PM020-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2019
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.All information reasonably known as of 10-may-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical, inc.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 avanos medical, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Avanos medical, inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the second of two reports.Refer to 2026095-2019-00084 for the first event.It was reported that the catheter broke off inside the patient.The catheter, which was placed in the incision for a total knee procedure, had broken proximally.The event occurred when the patient was in the hospital.The catheter was still sticking out from the surface of the skin, the patient was able to grasp and remove the remainder of the catheter without further incident.No resistance was met according to the physician, as the device was being pulled and removed by the patient.
Additional Manufacturer Narrative
The investigation has been completed.The complaint has been confirmed as a duplicate of report 2026095-2019-00083 which was identified as complaint (b)(4).No additional information will be submitted for report 2026095-2019-00085.All information reasonably known as of (b)(6)-2019 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 avanos medical, inc.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 avanos medical, inc.Avanos medical, inc.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 avanos medical, inc.Complaint database and identified as complaint (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 an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: ON-Q ANTIMICROBIAL EXPANSION KITS WITH SILVERSOAKER CATHETER 5 IN (12.5 CM)
• Common Device Name: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8601568
• Report Number: 2026095-2019-00085
• Device Sequence Number: 2293867
• Product Code: BSO
• UDI-Device Identifier: 30680651135354
• UDI-Public: 30680651135354
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: PM020-A
• Device Catalogue Number: 101353500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 07/09/2019
• Patient Sequence Number: 1