MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH DUAL SITES, 270 ML, 4 ML/HR (2+2 ML/HR); ELASTOMERIC LFR

Model Number	P270X4D
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, 0203010670, 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 28-feb-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).
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 first of two reports.Refer to 2026095-2019-00035 for the second event.Fill volume: 270 ml, flow rate: 4 ml/hr, procedure: unknown, cathplace: unknown, start date/time: (b)(6) 2019 at 0800, stop date/time: (b)(6) 2019 at 2054.It was reported the on-q device ran out in less than 40-hours, according to pharmacy the device should of lasted 67-hours.Upon assessment, there was no leak found at the insertion site.Additional information received (b)(6) 2019 stated the reporting pharmacist called to notify that the sample was discarded and not available to return anymore.No additional information was provided.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH DUAL SITES, 270 ML, 4 ML/HR (2+2 ML/HR)
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8384680
• Report Number: 2026095-2019-00034
• Device Sequence Number: 2327602
• Product Code: MEB
• UDI-Device Identifier: 30680651136726
• UDI-Public: 30680651136726
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2020
• Device Model Number: P270X4D
• Device Catalogue Number: 101367203
• Device Lot Number: 0203010670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/02/2019
• Patient Sequence Number: 1