MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q CATHETERS-SILVERSOAKER

Model Number	PM020-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
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.Root cause could not be determined.All information reasonably known as of 08 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 2026095-2019-00083 for the second report.It was reported on 18-apr-2019 that "two catheters broke.Other with patient at home.Broke at connection where clear sleeve connects.No issue with any part of catheter left in.Patient.Entire catheter was completely removed.No injury was reported." additional information received on (b)(6) 2019 indicated that the physician was contacted on (b)(6) 2019 regarding this incident."because some of 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.".
Additional Manufacturer Narrative
The lot number was provided.A review of the device history record is in-progress.The investigation remains in progress.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 halyard health 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.
Additional Manufacturer Narrative
The device history record for lot 0203134014 was reviewed and the product was produced according to product specifications.Root cause could not be determined.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 halyard health 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 CATHETERS-SILVERSOAKER
• Common Device Name: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; irvine CA 92618
• MDR Report Key: 8592826
• Report Number: 2026095-2019-00082
• Device Sequence Number: 2042421
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2019

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: Lay User/Patient
• Device Expiration Date: 06/09/2021
• Device Model Number: PM020-A
• Device Catalogue Number: 101353500
• Device Lot Number: 0203134014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 04/26/2019; 07/03/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/12/2019; 07/17/2019
• Patient Sequence Number: 1