MAUDE Adverse Event Report: AVANOS MEDICAL INC. ONQ SELECT-A-FLOW (SAF) PUMP WITH CATHETER

Model Number UNKNOWN

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Implant Pain (4561)

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.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: 545 ml, flow rate: 6ml/hr, procedure: complete knee replacement, catheter placement: knee, infusion start time: (b)(6) 2021 12:00 pm, infusion stop time: unknown.It was reported by the patient that he was experiencing pain, post-procedure.The onq select-a-flow (saf) pump was running at 6ml/hour to provide pain relief after a total knee replacement that occurred about 38 hours previous to the patient's call.The patient reported pain and swelling around the insertion site, and lots of pain in the patellar region.The patient was advised to seek medical attention.At the emergency room, the onq saf was discontinued.During a later phone call to the patient, the patient reported that he had called emergency medical services to take him to the er, as the pain was so severe he could not move.He claims that the catheter was "right along the nerve and causing severe pulsating pain." after removal the patient reported that the pain dissipated but that the area where it was inserted was still tender.The patient plans to discuss further with his anesthesiologist and surgeon.

• Brand Name: ONQ SELECT-A-FLOW (SAF) PUMP WITH CATHETER
• Type of Device: CATHETER
• 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12242285
• MDR Text Key: 269521091
• Report Number: 2026095-2021-00079
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2021

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: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 07/28/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other