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

Model Number CB004

Device Problem Improper Flow or Infusion (2954)

Patient Problems Skin Irritation (2076); Numbness (2415)

Event Date 06/13/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is in-progress.All information reasonably known as of 06 jul 2020 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).Device not returned.

Event Description

Fill volume: 500 ml, flow rate: 10 ml/hr, 8 ml/hr, 6 ml/hr, procedure: l rotator cuff repair, procedure date: (b)() 2020, cathplace: neck, infusion start time: (b)(6) 2020 1300, infusion stop time: (b)(6) 2020 2100.It was reported that the patient's pump infused in 24 hours.Patient does not have any side effects of fast flow.Patient's wife stated the patient came home with dial at 6ml/hr and during night increased to 10ml/hr.Patient tried to decrease the 8ml/hr in the morning but pain increased so increased back to 10ml/hr.Patient "still numb in arm and fingers." additional information received the same day indicated the patient's wife spoke to a physician who recommended the catheter be removed.Site appeared slightly red and irritated.

Manufacturer Narrative

Corrected data: d1 brand name, d4 model number.The device history record for lot 30004422 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Photos of the device were provided by the customer; however, root cause could not be determined.All information reasonably known as of 28 jul 2020 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.

• 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 - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 10236416
• MDR Text Key: 242645992
• Report Number: 2026095-2020-00109
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

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: 03/27/2022
• Device Model Number: CB004
• Device Catalogue Number: N/A
• Device Lot Number: 30004422
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 07/29/2020
• Patient Sequence Number: 1
• Treatment: MARCAINE 0.25%; STINGRAY ADAPTER
• Patient Age: 59 YR
• Patient Weight: 76