MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND; ELASTOMERIC - COMBO

Model Number	CB006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(appropriate health impact term/code not available); taking benadryl per doctors orders.The product involved in the report has been returned and is being processed for evaluation.The device history record for lot 30155147 was reviewed and the product was produced according to product specifications.All information reasonably known as of 22 may 2022 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).Device not returned.
Event or Problem Description
It was reported that the patient was experiencing a vesicular blistering rash post removal of onq pump at the insertion site.The patient reported that the rash had moved out of the immediate surgical site area and spread to their groin and lower; they were taking benadryl,per the doctors orders and they had a follow up appointment with the doctor the following day.The patient¿s current condition is unknown.
Additional Manufacturer Narrative
The actual sample from the reported event was returned for evaluation.Visual examination of the device revealed that none of the components exhibited visible damage, (there were no breaks in the catheter).The pump was refilled to the reported volume of 550ml (as indicated by the label on the sample), with 0.9% saline, the liquid exited the distal end of the catheter yielding a flow rate of 11.69 ml/hr, (which was within specification, with a +/-20% tolerance).Additionally, a leakage was observed near the proximal end of the catheter, in the area of the first black depth marker below the hub.A hole was observed, centered in the proximal-most depth marker.The hole appeared evenly circular, with smooth edges; no jagged tearing was observed.The reported event could not be confirmed as reported; therefore, the root cause is undetermined.All information reasonably known as of 13 jun 2022 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: 550ml.Flow rate: unknown.Procedure: total knee replacement.Cathplace: unknown.Infusion start time: (b)(6) 2022.Infusion stop time: (b)(6) 2022.

• Brand Name: ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND
• Common Device Name: ELASTOMERIC - 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 14476344
• Report Number: 2026095-2022-00055
• Device Sequence Number: 11964258
• Product Code: MEB
• UDI-Device Identifier: 00193494134747
• UDI-Public: 00193494134747
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2022

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: 09/27/2023
• Device Model Number: CB006
• Device Catalogue Number: N/A
• Device Lot Number: 30155147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• 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: ROPIVACAINE/NACL
• Patient Sex: Male