MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW; ELASTOMERIC - SAF

Model Number	CB004
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record and udi are in-progress.All information reasonably known as of (b)(6) 2024 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 reported event but is relaying the information 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.
Event or Problem Description
Fill volume: 360 ml.Flow rate: 6 ml/hr.Procedure: peripheral nerve block.Cathplace: left fascia iliaca block.Infusion start time: (b)(6) 2024 1202.Infusion stop time: (b)(6) 2024 1600.It was reported, ¿pediatric patient whose pain pump ran out eight hours before it was supposed to.The rate had been set and locked and the pump was delivering a higher rate since it ran out too quickly.¿ per additional information received on 16sep2024, the incident ¿resulted in increased pain which had to be managed by increasing narcotic and non-narcotic medications while patient was at home.Patient¿s mother called the hospital and spoke to the registered nurse (rn) regarding the situation.Medical doctor (md) was called for pain medications to help with increased pain patient was then experiencing.¿ oral medications prescribed were oxycodone, gabapentin, tylenol, and ibuprofen.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30252594, 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 25-aug2025 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as (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 PAIN RELIEF SYSTEM WITH SELECT-A-FLOW
• Common Device Name: ELASTOMERIC - SAF
• 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: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 20305461
• Report Number: 2026095-2024-00052
• Device Sequence Number: 8686354
• Product Code: MEB
• UDI-Device Identifier: 10193494134720
• UDI-Public: (01)10193494134720(240)101347205(17)251113(10)30252594
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2025

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: 11/13/2025
• Device Model Number: CB004
• Device Catalogue Number: CB004
• Device Lot Number: 30252594
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 08/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GABAPENTIN; IBUPROFEN; OXYCODONE; ROPIVACAINE 0.2%; TYLENOL
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 58 KG