MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number CB004

Device Problem Infusion or Flow Problem (2964)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device history record for lot 80400859 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 23 aug 2021 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).

Event Description

Fill volume: 500 ml.Flow rate: 8 ml/hr.Procedure: "achilles procedure." cathplace: unknown.Infusion start time: (b)(6) 2021 0920.Infusion stop time: (b)(6) 2021 0400.It was reported that "fast flow" event occurred.The patient called and stated the pump was "put in at 0745 after achilles procedure on friday (b)(6) [(b)(6) 2021] that was running at 8 ml/hr the entire time ran out on sunday morning at about 0400." pump infused in less than 2 full days.No side effects reported, but patient was in pain and was told the pump would run out on monday.Additional information received 03-aug-2021 indicated the infusion was started (b)(6) 2021 at 0920.The product was used in accordance with the instructions and facility conditions did not contribute to this event.The facility is not a new or inexperienced user.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR
• Type of Device: 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. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12361422
• MDR Text Key: 267941716
• Report Number: 2026095-2021-00086
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494134723
• UDI-Public: 00193494134723
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/24/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/24/2023
• Device Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: 80400859
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2021
• Initial Date FDA Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 0.25% MARCAINE.
• Patient Age: 37 YR
• Patient Weight: 89