MAUDE Adverse Event Report: Avanos Medical Inc. ON-Q C-Bloc, SAF and ONDEMAND, 400 ml x 1-7 +5 ml bolus/60min; Electronic - Combo

Model Number	CB005
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	Nerve Damage (1979)
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 in-progress.All information reasonably known as of 07-aug-2026 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, inc.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: unknown.Flow rate: unknown.Procedure: right tri-malleolar ankle open reduction and internal fixation.Cathplace: unknown.Date of procedure: (b)(6)2024.It was reported the patient was admitted for right tri-malleolar ankle open reduction and internal fixation surgery with a physician.Prior to the surgery, the patient was treated by anesthesiologists.The patient was recommended by the anesthesiologists to consent to the placement of a disposable pain pump ¿ "on-q pain relief system" ¿ to manage patient's post-operative pain.Prior to surgery, the physician performed the peripheral nerve block and catheter placement at the popliteal nerve on the patient's right leg.The placement of the block and catheter was done under ultrasound guidance.At the time of the placement of the block and catheter, the patient verbalized to the anesthesiologists of feeling a sharp sensation at the location of the block and catheter.A physician, who was overseeing the procedure, instructed the anesthesiologist to "back out" the needle /catheter when this occurred.These events were not reported or referenced in the patient's medical records.Following the procedure, patient was discharged home with the on-q pain pump.During the discharge process, the patient received very little instruction or guidance in the use of the on-q pain pump system.The on-q system given to the patient was the on-q pump with ondemand bolus button and select-a-flow variable rate controller bearing.Upon return home, the patient experienced difficulty with the use of the on-q pain pump including an instance where the blue bolus button was not working properly.The pain pump catheter was removed after four days as directed by the medical staff.As patient's post-surgical recovery continued, the patient began experiencing symptoms consistent with nerve injury in the right lower extremity.On (b)(6) 2025, the patient underwent an electromyography, a nerve conduction study.The study identified a right sciatic mononeuropathy involving motor and sensory fibers and resulting in significant axonal loss.The study identified a lesion located proximal to the branching of the tibial and common peroneal nerves.The study revealed active denervation that was noted as worse in the peroneal innervated musculature.The study revealed no visible recruitment in the right tibialis anterior muscle.The patient's physicians determined that the patient's loss of function in the right leg and foot was due to damage to the nerve that occurred during the nerve block and catheter placement or subsequent use of the infusion pump.No further information was available.

• Brand Name: ON-Q C-Bloc, SAF and ONDEMAND, 400 ml x 1-7 +5 ml bolus/60min
• Common Device Name: Electronic - Combo
• 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. 22116 ; MX 22116
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 50180741
• Report Number: 2026095-2026-00070
• Device Sequence Number: 15524298
• Product Code: MEB
• UDI-Device Identifier: 00193494134730
• UDI-Public: (01)00193494134730
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: Health Professional
• Device Model Number: CB005
• Device Catalogue Number: CB005
• Device Lot Number: 20121718
• 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: 07/08/2026
• Initial Report FDA Received Date: 08/07/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male