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

Model Number	PM020-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	10/09/2022
Type of Reportable Event	Serious Injury
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 02 nov 2022 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 complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21 cfr part 803, 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.
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving the same patient.This is the second of two reports.Refer to 2026095-2022-00117 for the first report.Fill volume: unknown ml.Flow rate: unknown.Procedure: removal of left ovary.Cathplace: laparotomy pfannenstiel incision.Infusion start time: unknown.Infusion stop time: unknown.It was reported, the patient had a 10 cm teratoma removed on (b)(6) 2022; the surgeon removed the left ovary with laparotomy p-fannenstiel incision, the surgeon used pm020-a (5" silver soaker catheter).On (b)(6) 2022, the on-q catheter was empty, it was removed at home.The patient reported the catheter came out easily; however, 6 hours later the patient complained of pain and slight swelling, there was no bleeding or oozing from catheter sites.On (b)(6) 2022, the patient was admitted back into the hospital, with a hematoma, where they were to undergo an ultrasound and possible drainage of the site.Additional information received on 17oct2022 the patient confirmed they did not experience any issues at the time of the catheter removal.They additionally reported, they remained in the hospital after a procedure to drain the left side abdominal hematoma (site where the catheter(s) were placed); an 18 g needle was used.The patient¿s hemoglobin reportedly dropped to 8 due to internal bleeding, it was stated to be increasing (present value unknown).Additionally, the patient reported they were on a couple of (unspecified) antibiotics for a peritoneal infection and on an unspecified pain medication for pain at the hematoma site; she was told she would have to be on antibiotics for ¿several weeks¿ and did not know when she would be released from the hospital.Other than discomfort at the hematoma site patient did not report any further symptoms.
Additional Manufacturer Narrative
All information reasonably known as of 6-jan-23 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 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 INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 15729863
• Report Number: 2026095-2022-00118
• Device Sequence Number: 19551469
• Product Code: BSO
• UDI-Device Identifier: 00193494135355
• UDI-Public: 00193494135355
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K051401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PM020-A
• Device Catalogue Number: 101353503
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 88 KG