MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW; ELASTOMERIC - SAF

Model Number CB004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Numbness (2415); Taste Disorder (4422)

Event Date 11/11/2022

Event Type  Injury  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 09-dec-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, 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.Device not returned.

Event Description

Avanos medical received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the second of two reports.Refer to 2026095-2022-00136 for the first event.Fill volume: 545 ml flow rate: 8 ml/hr.Procedure: acl reconstruction/meniscus repair/orthoscopy right knee.With acl reconstruction with quadriceps patella autograft and meniscus repair.Start date and time of procedure: (b)(6) 2022 at 1000 cathplace: unknown.It was reported the patient had a pump that was infusing at a rate of 8 ml/hr of 0.2% ropivacaine and experienced symptoms.The patient experienced "metal taste and tongue numbness.Clamping the infusion resolved the problem." the catheter was removed.All symptoms subsided.Additional detailed information notes healthcare provider instructed caregiver to clamp ball and call back in one hour.The caregiver then called back around 11pm and reported resolution of metallic taste but continues tongue numbness.Due to concerns for toxicity decision was made to remove catheter.The catheter was removed via telephone phone instructions with caregiver and the catheter verified tip was intact.The patient was taking oxycodone every 6-hours, he is now taking it every 4 hours overnight if needed.Aps (acute pain services) called on 12-nov-2022 at noon.The caregiver had reported full resolution of symptoms and full resolution of sensation in leg.Additional information received 22-nov-2022 stated patient's "pain management is fine now.".

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 06-jan-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, 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.

Manufacturer Narrative

The device history record for the reported lot number, 30156194, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The pump was received partially full.The device was evaluated.All flow rates yielded below or within specifications, however, no fast flow was confirmed.A root cause was not identified.All information reasonably known as of 27-jan-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, 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
• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 15954983
• MDR Text Key: 305242680
• Report Number: 2026095-2022-00137
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2024
• Device Model Number: CB004
• Device Catalogue Number: N/A
• Device Lot Number: 30156194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2021
• 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
• Treatment: 0.2% ROPIVACAINE; UNKNOWN CATHETER
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 89 KG