MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PUMP FIXED FLOW; ELASTOMERIC LFR

Model Number P400X4D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)

Event Date 10/09/2022

Event Type  Injury  

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 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.Device not returned.

Event Description

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 10cm teratoma removed on (b)(6) 2022; the surgeon removed the left ovary with laparotomy p-fannenstiel incision, the surgeon used p400x4d.On (b)(6) 2022, the on-q was empty, the catheter(s) were removed at home.The patient reported the catheter came out easily; 6 hours later the patient complained of pain and slight swelling, there was no bleeding or oozing from catheter sites.On 1(b)(6) 2022, the patient was admitted back into the hospital, with a hematoma, where they will undergo an ultrasound and possible drainage of the site.Additional information received on 17 oct 2022 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 18g 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.

Event Description

Infusion start time: (b)(6) 2022.Infusion stop time: (b)(6) 2022.

Manufacturer Narrative

All information reasonably known as of 09 jan 2023 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 PUMP FIXED FLOW
• Type of Device: ELASTOMERIC LFR
• 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: 15735579
• MDR Text Key: 303083692
• Report Number: 2026095-2022-00116
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494136765
• UDI-Public: 00193494136765
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: P400X4D
• Device Catalogue Number: 101367603
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 88 KG