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

Model Number	CB002
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Numbness (2415); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
4581-appropriate clinical signs, symptoms, conditions term/code not available: unspecified motor skills issue.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 21 mar 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.
Event or Problem Description
Fill volume: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown, infusion start time: unknown, infusion stop time: (b)(6) 2023.Fda medwatch / fda user facility report mw report (b)(4) reported, the onq pump infusion completed about 24 hours earlier than expected.The patient noted the pump [was] complete at 1900; the pump should have finished at 2200 the next day.The patient reported a return of motor and sensation after the infusion was noted to be complete; there were no reported signs of local anesthetic systemic toxicity (last).
Additional Manufacturer Narrative
The device history record for lot 30212652 was reviewed and the product was produced according to product specifications.All information reasonably known as of 05 may 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: 16599594
• Report Number: 2026095-2023-00033
• Device Sequence Number: 6094056
• Product Code: MEB
• UDI-Device Identifier: 00193494134693
• UDI-Public: 00193494134693
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/10/2025
• Device Model Number: CB002
• Device Lot Number: 30212652
• 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: 03/02/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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: UNSPECIFIED MEDICATION
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown