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

Model Number CB6004

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported "the family member of a patient called to say that the flow on their pump seemed to be faster than it should be.[the] pump had emptied earlier than they had been advised it would." there was no reported injury.

Manufacturer Narrative

The sample is reportedly available for this complaint but was not returned.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 28-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)(6).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 product involved in the report has been returned and is being processed 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, 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, 30188613, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The device was evaluated.During the evaluation of the samples, the reported incident was not replicated; therefore, the complaint was not confirmed.Per the instructions for use (ifu) the flow rate may be higher or lower at the first and last hours of infusion, and the labeled flow rates are based on the use of normal saline as diluent, if a different diluent/drug is used the viscosity could be affected and cause the flow rate to increase.Root cause could not be determined.All information reasonably known as of 02-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, 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: 16064694
• MDR Text Key: 308493924
• Report Number: 2026095-2022-00144
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2023

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 Model Number: CB6004
• Device Catalogue Number: N/A
• Device Lot Number: 30188613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 02/21/2023; 04/05/2023
• Supplement Dates FDA Received: 03/21/2023; 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• 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