MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SILVERSOAKER ANTIMICROBIAL CATHETER, 100 ML X 2 ML; CATHETERS

Model Number	PM032-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, 0203022133, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.All information reasonably known as of 11-jun-2020 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.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
Fill volume: unknown.Flow rate: unknown.Procedure: left foot bunionectomy.Cathplace: left foot.Date procedure: (b)(6) 2020.It was reported an on-q catheter kinked.The surgeon was unable to remove the catheter in the office.The patient required a return visit to the operating room to have the catheter removed.While the catheter was in place the patient's pain was "well controlled" and "the ball looked like it infused the medication." the catheter was removed in surgical setting and noted to be in two pieces.The patient was discharged home in stable condition.There was no reported injury.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SILVERSOAKER ANTIMICROBIAL CATHETER, 100 ML X 2 ML
• Common Device Name: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 10148889
• Report Number: 2026095-2020-00100
• Device Sequence Number: 11306856
• Product Code: MEB
• UDI-Device Identifier: 00193494137229
• UDI-Public: 00193494137229
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

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: Health Professional
• Device Expiration Date: 12/09/2020
• Device Model Number: PM032-A
• Device Catalogue Number: 101372203
• Device Lot Number: 0203022133
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/12/2020
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 89