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

Model Number	P400X4D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Pain (1994); Swelling/ Edema (4577)
Date of Event	11/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Fill volume: 550 ml.Flow rate: 4ml/hr.Procedure: laparoscopy for endometriosis.Cathplace: x2 catheters placed bilateral lower abdomen.Infusion start time: (b)(6) 2022.Infusion stop time: (b)(6) 2022.It was reported, that on (b)(6) 2022, the patient who had a dual onq pump developed pain, swelling, warmness, pus, and redness at the catheter insertion site four (4) days post op (at approximately 1 pm).The pump was removed due to the patients reported pain; the black tip(s) was present on both catheter tips, the pump(s) were not empty.The patient was advised to seek medical attention as soon as possible.The patient¿s current condition was not provided.Additional information received (b)(6) 2022 the patient¿s mother reported, the doctor prescribed antibiotics twice daily for 14 days.Additionally, four days later the patient was experienced redness, swelling, and pus to catheter insertion site on the left side only; the patient reportedly was running a low-grade fever of 101°f.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 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.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 05 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
• Common Device Name: 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: 15951782
• Report Number: 2026095-2022-00232
• Device Sequence Number: 12438608
• Product Code: MEB
• UDI-Device Identifier: 00193494136765
• UDI-Public: 00193494136765
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023
• 2 Devices were Involved in the Event: 1 2

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: P400X4D
• Device Lot Number: 30194812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: .5 % BUPIVICAINE.; BACTRIM DS 800 MG-160 MG TABLETS 2X DAY, 14 DAYS.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 64 KG