MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q* PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER* ANTIMICROBIAL CATHETERS, 270 ML; ELASTOMERIC LFR

Model Number	PM025-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
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 in-progress.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 17-aug-2018 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.(b)(4).
Event or Problem Description
Fill volume: unknown flow rate: unknown procedure: surgical procedure: video-assisted thoracoscopic surgery (vats) cathplace: unknown a medwatch form was received from the user facility directly via mail, stating "during removal of pain buster ball, one of the wires broke off and remained in patient." no additional information was provided.
Additional Manufacturer Narrative
The device history record for the reported lot number, 0202876380, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of (b)(6) 2018 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.

• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7798940
• Report Number: 2026095-2018-00088
• Device Sequence Number: 2076245
• Product Code: MEB
• UDI-Device Identifier: 30680651137181
• UDI-Public: 30680651137181
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: 06/17/2020
• Device Model Number: PM025-A
• Device Catalogue Number: 101371803
• Device Lot Number: 0202876380
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/28/2018
• Patient Sequence Number: 1
• Patient Age: 37 YR